MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNIV REV FEM BROACH 31MM; KNEE INSTRUMENT/TRIAL

Catalog Number	961683
Medical Device Problem Codes	Break (1069); Material Disintegration (1177)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/02/2017
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 the o-ring has started to disintegrate.
Additional Manufacturer Narrative
Additional narrative: the device associated with this report was not returned for examination.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 will be filed as appropriate.

• Brand Name: UNIV REV FEM BROACH 31MM
• Common Device Name: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6838050
• Report Number: 1818910-2017-23993
• Device Sequence Number: 124651
• Product Code: HTQ
• UDI-Device Identifier: 10603295239819
• UDI-Public: 10603295239819
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2017

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: 961683
• Device Lot Number: B1209
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 09/09/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 09/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR