MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PIN TRIAL SHELL 56 STD PROFILE; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	221701056
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/09/2018
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 two cross threaded pinnacle handles snap ring on 56 x 4 neutral trial liner disengaged.It was also indicated that the trial cup (56 mm) had damaged threads.Surgical delay of 2 mins.
Additional Manufacturer Narrative
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 # = > pc-(b)(4).Investigation summary = > 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, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # : (b)(4).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, a follow-up medwatch will be filed as appropriate.

• Brand Name: PIN TRIAL SHELL 56 STD PROFILE
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7568634
• Report Number: 1818910-2018-61301
• Device Sequence Number: 1262216
• Product Code: LXH
• UDI-Device Identifier: 10603295097679
• UDI-Public: 10603295097679
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/09/2018

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: 221701056
• Device Lot Number: NB39442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 06/08/2018; 07/02/2018; 08/01/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 06/27/2018; 07/06/2018; 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR