MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS CMP/SIGMA REV FEM SLV 34MM; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY

Model Number	1294-53-120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Intraoperatively during a planned knee surgery because of patella-upgrade the femoral component was found to be fractured.Doi: unknown, dor: (b)(6) 2021.Additionally a stem and sleeve component were reported as associated with the adverse event.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned devices revealed the femoral sleeve and stem components were loose with the femoral component.The degree of polishing/wear suggests motion between the two components for a significant portion of the service life of the components.No material or manufacturing defects were observed that could have contributed to the disassociation.The need for corrective action is not indicated.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 : dhr review: quantity manufactured: (b)(4) , date of manufacture: feb-2013 , any anomalies or deviations identified in dhr: no deviations or anomalies were found., expiry date: feb-2023 , ifu reference: ifu-0902-00-769.

• Brand Name: LCS CMP/SIGMA REV FEM SLV 34MM
• 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
• MDR Report Key: 11750471
• Report Number: 1818910-2021-09251
• Device Sequence Number: 14225967
• Product Code: NJL
• UDI-Device Identifier: 10603295026228
• UDI-Public: 10603295026228
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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
• Report Date (Section B): 04/21/2021

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: 1294-53-120
• Device Catalogue Number: 129453120
• Device Lot Number: 347956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 05/19/2021
• 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: LCS COMP VVC INS STD 17.5MM; MBT REVISION CEM TIB TRAY SZ 3; SIG TIB CEM STM 13X60 2/2.5/3; TAPER CEM STEM 13X90; UNK KNEE FEMORAL LCS; UNKNOWN KNEE FEMORAL AUGMENT; UNKNOWN KNEE FEMORAL AUGMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 110