MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PFC SIG RPF INS SZ 1.5 10MM; PFC SIGMA RP-F : KNEE TIBIAL INSERT

Model Number	95-1015
Medical Device Problem Codes	Loss of Osseointegration (2408); Naturally Worn (2988)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/23/2020
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) 2008 via tka.In june 2020, the patient complained of a malfunction.On (b)(6) 2020, the revision surgery was performed by replacing the tibial tray (p/n: 129433115) and the tibial insert (p/n: 951015).The surgeon replaced natural patella with a patella component.During the surgery, the surgeon confirmed the wear of the tibial insert and the loosening of the tibial tray.The femoral component was not loosened.A little wear was seemed at the explanted tibial tray¿s surface, and the surgeon checked damage level of the implants, he judged that there was no complaint about the implants.The revision surgery was completed without any surgical delay.No further information is available.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation : no device associated with this report was received for examination.A worldwide complaint database search found no other reported 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.H10 additional narrative: corrected: h6 (device).Removed code for loss of osseointegration.

• Brand Name: PFC SIG RPF INS SZ 1.5 10MM
• Common Device Name: PFC SIGMA RP-F : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10240398
• Report Number: 1818910-2020-15156
• Device Sequence Number: 2655545
• Product Code: NJL
• UDI-Device Identifier: 10603295230250
• UDI-Public: 10603295230250
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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): 06/23/2020

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: 95-1015
• Device Catalogue Number: 951015
• Device Lot Number: AE2EC4000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 07/27/2020
• 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: MBT CEM KEEL TIB TRAY SZ1.5.; UNKNOWN KNEE FEMORAL.; MBT CEM KEEL TIB TRAY SZ1.5; UNKNOWN KNEE FEMORAL
• Outcome Attributed to Adverse Event: Required Intervention