MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 36MM +3MM 11/13 HEAD TRIAL; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number	236532500
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
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
General wear, scratches on head making it difficult to read.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the instruments associated with this report were not returned.Depuy considers the investigation closed at this time.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.

• Brand Name: 36MM +3MM 11/13 HEAD TRIAL
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7761466
• Report Number: 1818910-2018-66011
• Device Sequence Number: 16415171
• Product Code: LXH
• UDI-Device Identifier: 10603295120049
• UDI-Public: 10603295120049
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2018

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: 236532500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1