MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC* MOD PLUS TIBIAL TRAY SZ 3; SIGMA REVISION IMPLANT : KNEE TIBIAL TRAY

Catalog Number	860123
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	06/28/2018
Type of Reportable Event	Serious Injury
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 tkr; dr (b)(6) - (b)(6) hospital (b)(6) 2018 - patient underwent primary total knee replacement ; primary date to be confirmed, where a pfc ps fixed implant was utilized (dr (b)(6)).Patient has reported that since the primary surgery she has been very unhappy with her knee, experiencing both pain and instability from day 1.Previous surgical notes have not been made available but x rays indicated some form of issue with the extensor mechanism; with patella alto and anchors visible on x ray (indicating possible patella tendon pull off or rupture.On opening the knee (dr (b)(6), (b)(6), (b)(6) 2018) the femoral and tibial components were found to be well fixed.The knee was unstable through a range of motion with imbalanced gaps through both extension and flexion.Components were removed and an attune revision implant utilised.Femoral component was externally rotated by approx 8 degrees to balance the flexion gap.Knee was stable through the range.Patella component was revised and the patella tendon repaired utilising a lars ligament.Female patient initials (b)(6), aged (b)(6), dob: (b)(6).Discarded unknown jrn: 1 x pfc ps femoral component.Discarded unknown jrn: 1 x pfc dome patella.Discarded unknown jrn: 1 x 12032904 - pfc ps insert fixed size 3 10mm.
Additional Manufacturer Narrative
Investigation summary: the device associated with this report was not returned for evaluation.Photographs were provided for review.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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. .

• Common Device Name: SIGMA REVISION IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7719243
• Report Number: 1818910-2018-65218
• Device Sequence Number: 13729936
• Product Code: JWH
• UDI-Device Identifier: 10603295215448
• UDI-Public: 10603295215448
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K884796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018

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: 860123
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 10/05/2018
• 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
• Patient Age: 72 YR