MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMPLETE M/B PAT POR LG; LCS COMPLETE : KNEE PATELLA

Model Number	1294-09-660
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Surgeon performed a revision tkr today; exchanged bearing and patella.Tibial bearing had strange wear on medial side, with some faint crazing.Patella appeared unworn.Surgeon requested analysis of poly.Reference number 1294-05-612, lot number 298095, lcs complete tibial insert rotating platform 12.5mm size large implanted 2013.
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 which has not been investigated or verified 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device did not identify any defects or anomalies.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: no manufacturing deviations or anomalies were identified.
Additional Manufacturer Narrative
Product complaint # :pc-(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified 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.
Event or Problem Description
Additional information received stating that the affected side involved in this event was the left side.Depuy cmw 2 gentamicin bone cement was used.Patella is not worn.

• Brand Name: LCS COMPLETE M/B PAT POR LG
• Common Device Name: LCS COMPLETE : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11596532
• Report Number: 1818910-2021-06650
• Device Sequence Number: 17006647
• Product Code: NJL
• UDI-Device Identifier: 10603295022664
• UDI-Public: 10603295022664
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/15/2021

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: 1294-09-660
• Device Catalogue Number: 129409660
• Device Lot Number: 3468864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 04/05/2021; 04/12/2021; 04/30/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 04/20/2021; 04/23/2021; 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPUY CMW 2G 40G; LCS COMP RP INSERT LG 12.5MM; LCS COMP RP INSERT LG 12.5MM; LCS COMPLETE FEM POR L LG; LCS COMPLETE M/B PAT POR LG; MBT CEM KEEL TIB TRAY SZ4; LCS COMP RP INSERT LG 12.5MM; LCS COMP RP INSERT LG 12.5MM; LCS COMPLETE FEM POR L LG; LCS COMPLETE M/B PAT POR LG; MBT CEM KEEL TIB TRAY SZ4
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 70