MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMP RP INSERT STD 12.5MM; LCS COMPLETE : KNEE TIBIAL INSERT

Model Number	1294-05-412
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Scar Tissue (2060); Joint Laxity (4526)
Date of Event	01/01/2021
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
Complaints were extracted from the attached file "service evaluation of the lcs tini product".Loosening (4x): 2x 1-2 years after surgery, 1x 2-3 years after surgery, 1x 3-5 years after surgery.Infection (3x): 1x less than 1 year, 1x 3-5 years after surgery, 1x 5-10 years after surgery, other (1x), 1x 2-3 years after surgery (soft tissue revision only - permanent problems, lump, effusion etc.) this complaint captures 1 with loosening 3-5 years after surgery.On (b)(6) 2010, the patient had a total knee replacement right knee.It was noted that the patient is allergic to nickel.Depuy components were implanted during this procedure.No intraoperative complications were noted.On (b)(6) 2014, xray was noted to show a radiolucent line formation on the femoral part.A mobilization under anesthesia was performed to release scar tissue.On (b)(6) 2014 patient was revised.Revision details included insufficiency of the medial collateral ligaments, which lead to this implant exchange.(instability) during the procedure the surgeon observed ossus overgrowth of the implant edges which were removed.Femoral, tibial tray, and insert were revised.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device was not returned.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.It is not possible to confirm a depuy's product failure as well as a relation between the adverse event and the reported product.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 : a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: LCS COMP RP INSERT STD 12.5MM
• Common Device Name: LCS COMPLETE : 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13017879
• Report Number: 1818910-2021-28273
• Device Sequence Number: 12044001
• Product Code: NJL
• UDI-Device Identifier: 10603295022022
• UDI-Public: 10603295022022
• 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: 2010
• Device Explanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2021

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: 1294-05-412
• Device Catalogue Number: 129405412
• 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: 12/06/2021
• Supplement Date Received by Manufacturer: 12/24/2021; 03/04/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 01/13/2022; 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 STD 12.5MM; LCS COMP TN FEM POR RT STD; MBT TN POR TIB TRAY SZ2.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 82 KG