MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN TRL LNR +4 10D 52ODX32ID; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	221832152
Medical Device Problem Codes	Naturally Worn (2988); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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
Complaint not specific to one case.Surgeons complain that pinnacle poly trials are worn and used, scratches on them and screws worn out.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary the instrument associated with this report was 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 will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the instrument associated with this report was 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.Product received 04 dec 2018.Examination of the returned instrument confirmed the complaint.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 will be filed as appropriate.

• Brand Name: PIN TRL LNR +4 10D 52ODX32ID
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8025479
• Report Number: 1818910-2018-74076
• Device Sequence Number: 16495677
• Product Code: LXH
• UDI-Device Identifier: 10603295100836
• UDI-Public: 10603295100836
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2018

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: 221832152
• Device Lot Number: SZ1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 11/05/2018; 12/18/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 11/06/2018; 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1