RSP 508-32-101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-27 for RSP 508-32-101 manufactured by Encore Medical L.p..

Event Text Entries

[186299717] The reason for this revision surgery was reported as pain. The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or could be established. The healthcare professional indicated there was no delay in surgery and another suitable device was available for use. The revision surgery was completed as intended. The devices were disposed of at hospital and not made available to djo surgical for examination. The revised items were not returned for examination and the item number and lot numbers were not provided. To adequately investigate this event, the item number and lot numbers are necessary. If this information is submitted at a future date, this investigation will be re-evaluated. There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event. The surgeon performed this revision to remedy the patient's condition. This complaint will be closed pending receipt of additional information.
Patient Sequence No: 1, Text Type: N, H10


[186299718] Revision surgery - patient presented with pain to the surgeon.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1644408-2020-00258
MDR Report Key9889221
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-02-28
Date Mfgr Received2020-02-28
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTEFFANY HUTTO
Manufacturer Street9800 METRIC BLVD
Manufacturer CityAUSTIN, TX 78758-5445,
Manufacturer CountryUS
Manufacturer G1ENCORE MEDICAL L.P.
Manufacturer Street9800 METRIC BLVD
Manufacturer CityAUSTIN, TX 78758-5445,
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRSP
Generic NameGLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/NEUTRAL
Product CodePHX
Date Received2020-03-27
Model Number508-32-101
Catalog Number508-32-101
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerENCORE MEDICAL L.P.
Manufacturer Address9800 METRIC BLVD AUSTIN, TX 78758-5445, US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-27

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