MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM LT SZ5; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0005
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision of a pfc tkr done in 2006.Male, left side.On the joint registry form, the reason for revision was due to deep infection, tibial loosening, femur loosening.When exposure was done the surgeon noted significant poly wear as seen in the pics.All components were removed and attune revision was implanted.Doi: (b)(6) 2006.Dor: (b)(6) 2023.Left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary; the device associated with this report was not returned to depuy synthes for evaluation.Review of the photographic evidence was not able to confirm the complaint.No series of chronological x-ray was provided and no signs of implant loosening on the explanted device were observed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot; a manufacturing records evaluation (mre) was not performed as no lot number was able to be retrieved for this device.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary; the device associated with this report was not returned to depuy synthes for evaluation.Review of the photographic evidence found nothing indicative of a device nonconformance or a relation to the reported adverse event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot; a manufacturing records evaluation (mre) was not performed as no lot number was able to be retrieved for this device.

• Common Device Name: SIGMA KNEE PRIMARY : 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: 16502360
• Report Number: 1818910-2023-05314
• Device Sequence Number: 6259782
• Product Code: JWH
• UDI-Device Identifier: 10603295231974
• UDI-Public: 10603295231974
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 03/08/2023

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: 96-0005
• Device Catalogue Number: 960005
• 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: 02/22/2023
• Supplement Date Received by Manufacturer: 03/10/2023; 03/14/2023; 05/22/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 03/13/2023; 03/17/2023; 05/23/2023
• 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: PFC KEEL TIB TRAY CEM SZ5; PFC*SIGMA C/R NPOR FEM LT SZ5; SIGMA CRVD GVF INS 5 10MM; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male