MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC KEEL TIB TRAY CEM SZ5; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Model Number	86-4183
Medical Device Problem Code	Loss of or Failure to Bond (1068)
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.The patient notes were unavailable so i was unable to get the lot numbers from the implant stickers.The only lot number i was able to read on the implants was for the one stated in the impacted products.86-4183 pfc keeled tibial tray sz 5.The tibia was very loose.As you can see in the pic there is cement on the implant, so both interfaces failed.The femur failed at the bone-cement interface.
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.Extraction marks can be observe on the tibial tray.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot; the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records (mre) was not performed.
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.Extraction marks can be observe on the tibial tray.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records (mre) was not performed.

• Brand Name: PFC KEEL TIB TRAY CEM SZ5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16501657
• Report Number: 1818910-2023-05278
• Device Sequence Number: 19671136
• Product Code: JWH
• UDI-Device Identifier: 10603295216452
• UDI-Public: 10603295216452
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K961685
• 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
• Device Model Number: 86-4183
• Device Catalogue Number: 864183
• Device Lot Number: 2067657
• 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: 02/23/2023
• Supplement Date Received by Manufacturer: 03/10/2023; 03/14/2023; 05/17/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 03/13/2023; 03/17/2023; 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2006
• 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*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