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

Catalog Number 860123

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 06/28/2018

Event Type  Injury  

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 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.

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. .

• Type of Device: SIGMA REVISION IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7719243
• MDR Text Key: 115000341
• Report Number: 1818910-2018-65218
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295215448
• UDI-Public: 10603295215448
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K884796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 860123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR