MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PFC SIG RPF CEM FEM SZ 5 LT; PFC SIGMA RP-F : KNEE FEMORAL

Model Number	95-0016
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/17/2020
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
Patient underwent left primary tkr in 2006.At this time a primary pfc rpf femoral component size 5 left and a cementless duofix mbt tray was utilised (cat numbers and lot numbers could not be established).Patient has done well for a number of years (undertaking manual work) and started to feel pain in the last 2 years.X-rays show a loose femoral component along with wear of the tibial insert on the medial side.On opening the knee the femoral component was obviously loose (this component had debonded at the implant cement interface and showed signed of polishing where there had been movement between the cement and the implant).Granulomas soft tissue was excised from the extensor mechanism, and there were eteolytic lesions in the distal femoral bone.The duofix tray was not overtly loose but did come away from the tibial bone without too much effort.The patella component was left in situ.An attune revision component was implanted along with both femoral and tibial sleeves.Good stability and fixation were achieved.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: dhr reviewed no deviations or non-conformances were noted.

• Brand Name: PFC SIG RPF CEM FEM SZ 5 LT
• Common Device Name: PFC SIGMA RP-F : KNEE FEMORAL
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11113522
• Report Number: 1818910-2021-00127
• Device Sequence Number: 19731959
• Product Code: NJL
• UDI-Device Identifier: 10603295224044
• UDI-Public: 10603295224044
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2020
• 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): 12/17/2020

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: 95-0016
• Device Catalogue Number: 950016
• Device Lot Number: Z47NT4000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 03/11/2021
• 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: DEPUY DUOFIX MBT TRAY SZ 5; PFC SIG RPF INS SZ 5 10MM; PFC*SIGMA/OV/DOME PAT 3PEG,35
• Outcome Attributed to Adverse Event: Required Intervention