MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN TRL LNR+4 NEUT 52ODX28ID; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	221828452
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2019
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
The 28/52+4neutral trial liner ring became dissociated from the trial.The trial appeared in tact when it was placed on the mayo stand after being removed from the patient.When instruments were being replaced after the case ended, it was noticed that the trial was in two pieces.The ring that holds them together was not in tact or found.Based on implant ct image and x-rays, it does not appear the ring is in the patient.However, the ring was not found anywhere in the room.There is a chance that the ring could between the poly and the cup.
Additional Manufacturer Narrative
Product complaint # (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.H10 additional narrative: added: h6device code) corrected: h3(closure codes) product complaint # :(b)(4).Investigation summary = > examination of the returned instrument confirmed the reported observation.The root cause is attributed to misuse and heavy usage.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.Device history lot = > null.Device history batch = > null.Device history review = > null.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 TRL LNR+4 NEUT 52ODX28ID
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9385199
• Report Number: 1818910-2019-118486
• Device Sequence Number: 2207573
• Product Code: LXH
• UDI-Device Identifier: 10603295100560
• UDI-Public: 10603295100560
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2019

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: 221828452
• Device Lot Number: J0803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 12/19/2019; 01/03/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 12/26/2019; 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR