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

Catalog Number	951030
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	09/27/2019
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
The customer reports that a total knee prosthesis was implanted on (b)(6) 2017: a cement palacos r40 + gentamicine code product 66017750 and lot number 85654581 revision on (b)(6) 2019 to remove and to change the prosthesis.During the revision, we noticed an abnormal mobility of the tibial implant which was removed without problem.A prosthesis with a hinge was implanted.
Additional Manufacturer Narrative
Product complaint # (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
Revision was done for chronic pain.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.H10 additional narrative: product complaint (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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: 9278464
• Report Number: 1818910-2019-114045
• Device Sequence Number: 19536061
• Product Code: NJL
• UDI-Device Identifier: 10603295230373
• UDI-Public: 10603295230373
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/08/2019

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: 951030
• Device Lot Number: 438943
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 10/08/2019; 11/28/2019; 01/06/2020
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 11/05/2019; 12/26/2019; 01/06/2020
• 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: CIMENT PALACOS R40 + GENTAMICINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 65