MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 18MM; KNEE HINGED TIBIAL INSERT

Catalog Number	198727118
Medical Device Problem Codes	Disassembly (1168); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2017
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
It was reported that hinge insert was found to be broken/separated into two parts.The metal post was dislocated from the poly.
Additional Manufacturer Narrative
(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, a follow-up medwatch will be filed as appropriate. .

• Brand Name: LPS UNIV TIB HIN INS XSM 18MM
• Common Device Name: KNEE HINGED TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7109763
• Report Number: 1818910-2017-51399
• Device Sequence Number: 13755770
• Product Code: KRO
• UDI-Device Identifier: 10603295079422
• UDI-Public: 10603295079422
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2017

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 Catalogue Number: 198727118
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 09/10/2018
• 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: 86 YR