MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN TRL LNR +4 NEUT 580DX32ID; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	221832458
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
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The investigation could not draw any conclusions regarding the reported event.Based on the inability to determine a root cause, the need for corrective action was not indicated.Product received 11 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.

• Brand Name: PIN TRL LNR +4 NEUT 580DX32ID
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8020609
• Report Number: 1818910-2018-73880
• Device Sequence Number: 11121465
• Product Code: LXH
• UDI-Device Identifier: 10603295101062
• UDI-Public: 10603295101062
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 221832458
• Device Lot Number: CY1104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1