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

Model Number	1294-05-312
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	03/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A-7334605 - may 13 2022.Lot # bf0225432, added in the area unrecognized number for (b)(4).The device was received at pal jrz.13/may/2022.No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.Biddle & reath llp.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Rupture of the femoral component with femoral bone erosion and fracture of the medial and lateral cortex.Revision surgery necessary.Surgeon refers that the patient had severe hypokinetic syndrome due to progressive inability to walk.
Additional Manufacturer Narrative
A-7334605 - may 13 2022.Lot # bf0225432, added in the area unrecognized number for (b)(4).The device was received at (b)(4).13/may/2022.The device associated with this report was received for examination.Visual examination of the device exhibited a remarkable worn condition on the condyles bearing area.Also, due to wear on one of the edges of the poly insert, a portion was fractured and separated from the rest of the part.The separated portion was not returned for examination.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 lot number was not able to be retrieved in the investigation.H10 additional narrative: added: b1, b2, d4 (lot), d10 corrected: b3, h3.

• Brand Name: LCS COMP RP INSERT MED 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14827902
• Report Number: 1818910-2022-11773
• Device Sequence Number: 4813050
• Product Code: NJL
• UDI-Device Identifier: 10603295021957
• UDI-Public: 10603295021957
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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): 06/27/2022

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: 1294-05-312
• Device Catalogue Number: 129405312
• Device Lot Number: BF0225432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 COMPLETE FEM POR R MED; MBT POR TIBIAL TRAY SZ2
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown