MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-06 for 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/LEFT 02.124.409 manufactured by Wrights Lane Synthes Usa Products Llc.
[178020706]
Additional product code hrs, hwc. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[178020707]
It was reported that on (b)(6) 2020, the patient underwent a revision procedure to remove the broken variable angle locking compression plate (va-lcp) curved condylar plate and two (2) of the 4. 5 mm cortex screws on femur. The patient experienced pain, nonunion and delayed healing. Originally, the patient had an initial surgery last (b)(6) 2018 where the reported devices were implanted. During the revision procedure, all the original implants were successfully removed including the generated fragments from the broken devices. Fragments were removed easily without additional intervention. The patient was revised to a retrograde/ antegrade femoral nail (rafn). The procedure was successfully completed without surgical delay. Patient status was good. Concomitant devices reported: unknown va locking screws, (part # unknown, lot # unknown, quantity 4), unknown va cannulated locking screws, (part # unknown, lot # unknown, quantity 4), unknown cortex screw (part # unknown, lot # unknown, quantity 1). This is report 01 of 03 of (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-00666 |
| MDR Report Key | 9677109 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-06 |
| Date of Report | 2020-01-15 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | WERK MEZZOVICO (CH) |
| Manufacturer Street | VIA CAVAZZ 5 |
| Manufacturer City | MEZZOVICO 6805 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6805 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/LEFT |
| Generic Name | IMPLANT,FIXATION DEVICE, CONDYLAR PLATE |
| Product Code | JDP |
| Date Received | 2020-02-06 |
| Model Number | 02.124.409 |
| Catalog Number | 02.124.409 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-06 |