MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LPS UNIV TIB HIN INS XSM 18MM; KNEE TIBIAL BEARING/INSERT

Catalog Number	198727118
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that on investigation of the explant we noticed that the central metal part of the peg with hinge ring had separated from the rest of the insert.
Additional Manufacturer Narrative
(b)(4).Examination of the returned device confirmed the reported disassociation.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: LPS UNIV TIB HIN INS XSM 18MM
• Common Device Name: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7161433
• Report Number: 1818910-2018-10012
• Device Sequence Number: 18847891
• Product Code: KRO
• UDI-Device Identifier: 10603295079422
• UDI-Public: 10603295079422
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 198727118
• Device Lot Number: BFA0BAX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1