MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS M BRDG BRG STD+/LG 10.0; LCS : KNEE TIBIAL INSERT

Model Number	1278-24-025
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2022
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
Surgeon reported to bfarm: "revision of knee-tep right side on (b)(6) 2022 after approximately 20 years - fracture of the femoral lcs classic shield.Medial femoral condyle shows a transverse implant fracture (images are available upon request).Pe inlay corresponding (full-layer wear).The implant was scrapped at the patient's request." doi: (b)(6) 2001.Dor: (b)(6) 2022.Right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary device associated with this report was not received for examination.All available x-rays and photographs were reviewed.Based on the provided evidence, the worn condition cannot be confirmed.Nevertheless, it was observed that the lcs m brdg brg std+/lg 10.0 (product code: 127824025, lot number: uc6r51010) has fractured in two pieces.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: bfarm dhr review.Product description: lcs m brdg brg std+/lg 10.0.Product code: 127824025.Lot number: uc6r51010.1) quantity manufactured: (b)(4).2) date of manufacture: 01/2000.3) any anomalies or deviations identified in dhr: none.No non-conformances.4) expiry date: n/a 5) ifu reference: (b)(4) ifu, lcs knee system rev.1.Device history review: 1) quantity manufactured: (b)(4).2) date of manufacture: 01/2000.3) any anomalies or deviations identified in dhr: none.No non-conformances.4) expiry date: n/a.5) ifu reference: 090200682 ifu, lcs knee system rev.1 corrected: h4.

• Brand Name: LCS M BRDG BRG STD+/LG 10.0
• Common Device Name: LCS : KNEE TIBIAL INSERT
• 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: 14977228
• Report Number: 1818910-2022-12707
• Device Sequence Number: 14711153
• Product Code: NJL
• UDI-Device Identifier: 10603295020400
• UDI-Public: 10603295020400
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• 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
• Report Date (Section B): 07/11/2022

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 Model Number: 1278-24-025
• Device Catalogue Number: 127824025
• Device Lot Number: UC6R51010
• 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: 06/24/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2000
• 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 FEM 70MM STD+ RT; LCS TEX PCR TIB PLAT LG
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female