MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PFC SIG RPF INS SZ 2 10MM; PFC SIGMA RP-F : KNEE TIBIAL INSERT

Catalog Number	951020
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	02/19/2019
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
Painful post-op.This case is from health authority.It was reported that the patient underwent bilateral knee arthroplasty in order to restore joint function due to osteoarthritis of both knees 5 years ago.Johnson & johnson pfc sigma rpf total knee system was used in the surgery on (b)(6) 2014.The patient's left knee recovered well after surgery, and the right knee function recovered unsatisfactorily with instability and felt joint painful during walking.She was diagnosed with instability after right knee arthroplasty on (b)(6) 2019 and underwent a right knee revision procedure on (b)(6) 2019.Intraoperative observations were consistent with a diagnosis of instability, and it was not related to joint implant, it is related to surgery or patient.The patient's joint function recovered after revision surgery.
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.Device history lot: null.Device history batch: null.Device history review: null.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 2 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: 9000711
• Report Number: 1818910-2019-104031
• Device Sequence Number: 365479
• Product Code: NJL
• UDI-Device Identifier: 10603295230298
• UDI-Public: 10603295230298
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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 Catalogue Number: 951020
• Device Lot Number: 341270
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 11/18/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 63 YR