MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC KEEL TIB TRAY CEM SZ4; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Catalog Number	864182
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/04/2018
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
Revision total knee replacement; (b)(6), (b)(6) hospital (b)(6) 2018.Primary date unknown.1st revision was performed on (b)(6) 2014 after a fall and patella fracture.The patella and tibial liner was replaced at this revision.I have not been able to establish primary surgical date.On (b)(6) 2018 exploration of total knee undertaken due to patient presenting with knee pain.On examination of the tibial tray it was noted to be loose.The surgeon stated that the patient had a fall in 2014 which lead to a patella fracture.The tibial tray and liner was removed and replaced with a revision mbt tray and cr rp liner.No supporting documentation available.Male patient initials (b)(6), aged (b)(6) years, dob: (b)(6), weight: (b)(6) kgs.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination 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 KEEL TIB TRAY CEM SZ4
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7637186
• Report Number: 1818910-2018-63115
• Device Sequence Number: 2482298
• Product Code: JWH
• UDI-Device Identifier: 10603295216445
• UDI-Public: 10603295216445
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040166
• 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): 06/03/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2020
• Device Catalogue Number: 864182
• Device Lot Number: 3062426
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2018
• Supplement Date Received by Manufacturer: 12/02/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 12/04/2018
• 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: 57 YR
• Patient Weight: 140