MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL FEM SLV FUL POR 31MM; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY

Model Number	1294-53-216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that implants were inserted on 2 different dates as a partial revision was performed on the second date, 5-57-21.A der was submitted at that time.First 3 items listed were left from 1-29-20 procedure, the rest were placed in may 21.Patient complained of tibial pain.Xrays appeared to have lucencies on the tibial side so a tibial side revision was planned.Insert and femoral component were removed for exposure, then tibial tray and stem were removed, but the tibial sleeve was found to be well fixed.The surgeon wanted to shorten the adapter on the femoral sleeve and when trying to remove the adapter the femoral sleeve and stem were extracted.At this point, a tibial and femoral revision were perfumed uneventfully.There was no patient harm.Doi: (b)(6) 2020 dor: (b)(6) 2022 affected side: right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: the device associated with this complaint was not returned.Photo evidence of x-rays provided was reviewed and no product issue was identified.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product code 129453216 /lot code j5028h combination.Based on the inability to find any nc¿s against the provided product code /lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNIVERSAL FEM SLV FUL POR 31MM
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15526005
• Report Number: 1818910-2022-19291
• Device Sequence Number: 17640004
• Product Code: JWH
• UDI-Device Identifier: 10603295026273
• UDI-Public: 10603295026273
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1294-53-216
• Device Catalogue Number: 129453216
• Device Lot Number: J5028H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 11/11/2022; 11/11/2022
• Initial Report FDA Received Date: 10/01/2022
• Supplement Report FDA Received Date: 11/14/2022; 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE REV LPS INSRT XSM 12MM; ATUN TIB SLV M/L 29MM HALF POR; ATUNE PRESSFIT STR STEM12X60MM; ATUNE REV RP TIB BASE SZ 2 CEM; CONTROL CABLE W/CABLE SLEEVE; LPS DISTAL FEM COMP XSM RT; LPS FEM TO SLEEVE ADAPTER +5; UNIVERSAL STEM 75X14MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 77 KG