MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PFC SIG RPF INS SZ 3 10MM; PFC SIGMA RP-F : KNEE TIBIAL INSERT

Model Number	95-1030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	12/05/2019
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
Bearing exchange for tkr;patient underwent primary tkr on (b)(6) 2008, where pfc rpf components were utilized.Patient was doing well up until approximately 3 years ago when she started to feel a little pain.This pain has progressed steadily.A decision was made to open the knee and review the soft tissue balance (unbalanced soft tissue was believed to be the cause of her pain).The knee was taken through a range of motion and it appeared to be loose through the rom.A decision was made to increase the thickness of the poly from a 10mm to a 15mm.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # : (b)(4).Investigation summary : 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFC SIG RPF INS SZ 3 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: 9520408
• Report Number: 1818910-2019-124680
• Device Sequence Number: 16266324
• Product Code: NJL
• UDI-Device Identifier: 10603295230373
• UDI-Public: 10603295230373
• 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: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 95-1030
• Device Catalogue Number: 951030
• Device Lot Number: CG5HS4000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 02/10/2020
• 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: DEPUY DUOFIX MBT TRAY SZ 3; PFC SIG RPF CEM FEM SZ 3 LT; PFC SIGMA/OV/DOME PAT 3PEG,35
• Outcome Attributed to Adverse Event: Required Intervention