MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-09 for FEMORAL HEAD STERILE PRODUCT N/A 00801803602 manufactured by Zimmer Manufacturing B.v..
[174288258]
(b)(4). Concomitant medical products: zimmer head cat#00801803602 lot#63181235, zimmer liner cat#00630505036 lot#63165575, zimmer cup cat#00620205222 lot#61132699, zimmer stem cat#00771300700 lot#60825861, zimmer neck cat#00784803300 lot#62124936. The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018? 03921, 0002648920 - 2020 - 00022.
Patient Sequence No: 1, Text Type: N, H10
[174288259]
It was reported that a patient underwent left hip procedure. Approximately 6 years later patient was revised. Approximately 1 year later patient was revised again. Subsequently, 2 years later patient was revised due to metallosis and elevated cobalt chrome levels. No further event information available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002648920-2020-00022 |
| MDR Report Key | 9568663 |
| Report Source | CONSUMER |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-09 |
| Date of Event | 2018-07-25 |
| Date Mfgr Received | 2019-12-16 |
| Device Manufacturer Date | 2015-12-11 |
| Date Added to Maude | 2020-01-09 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER MANUFACTURING B.V. |
| Manufacturer Street | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 |
| Manufacturer City | MERCEDITA PR 00715 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00715 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEMORAL HEAD STERILE PRODUCT |
| Generic Name | PROSTHESIS, HIP |
| Product Code | JDL |
| Date Received | 2020-01-09 |
| Model Number | N/A |
| Catalog Number | 00801803602 |
| Lot Number | 63181235 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER MANUFACTURING B.V. |
| Manufacturer Address | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 MERCEDITA PR 00715 US 00715 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-01-09 |