MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMPLETE FEM POR R LG; LCS COMPLETE : KNEE FEMORAL

Model Number	1294-04-060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/31/2022
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
Revision surgery of lcs from 2012.The posterior condyle of the femur has fractured off in situ.Visualised on xray and ct and found in surgery.In addition it was a late discovery and the only kit we could get to the hospital with it a 12 hour time period was a hinge.Doi: 2012; dor: (b)(6) 2022; unknown side.
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).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
Affected side: right knee.
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.
Event or Problem Description
Additional information received indicated that the posterior condyle of the femur had fractured off in situ.No delay reported.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary = > the device associated with this complaint and was returned to depuy synthes and then sent to warsaw metallurgy team for evaluation.The photo investigation and visual examination found the device broken.The reported allegation can be confirmed.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 = > the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mrae) was not performed.H3.

• Brand Name: LCS COMPLETE FEM POR R LG
• Common Device Name: LCS COMPLETE : KNEE FEMORAL
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14696816
• Report Number: 1818910-2022-10920
• Device Sequence Number: 5262921
• Product Code: NJL
• UDI-Device Identifier: 10603295021711
• UDI-Public: 10603295021711
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/15/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 1294-04-060
• Device Catalogue Number: 129403060
• Device Lot Number: 3574182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 06/24/2022; 06/29/2022; 08/24/2022; 10/25/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 06/28/2022; 07/04/2022; 08/26/2022; 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2013
• 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: LCS COMP RP INSERT LG 12.5MM; MBT CEM TIBIAL TRAY SZ5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male