MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PFC SIG RPF CEM FEM SZ 2 LT; PFC SIGMA RP-F : KNEE FEMORAL

Model Number	95-0012
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/17/2020
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
The primary surgery was performed on (b)(6) 2009 via tka for the patient¿s left knee.It was reported that the revision surgery was performed on (b)(6) 2020 by replacing the femoral component (p/n: 950012), the tibial insert (p/n: 951020) and the tibial tray (p/n: 129433120) due to loosening.The surgery was completed, and it was unknown whether there was a surgical delay or not.No further information is available.
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no additional related incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFC SIG RPF CEM FEM SZ 2 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: 9922139
• Report Number: 1818910-2020-10140
• Device Sequence Number: 3257212
• Product Code: NJL
• UDI-Device Identifier: 10603295224006
• UDI-Public: 10603295224006
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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: 95-0012
• Device Catalogue Number: 950012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention