MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN TRL LNR NEUT 48ODX28ID; HIP INSTRUMENTS : ACETABULAR TRIALS

Model Number 2218-28-048

Device Problems Material Twisted/Bent (2981); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

Event Type  malfunction  

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 Description

Surgeon indicated neutral 28/48 trial liner was loose and worn due to wear and tear.No surgical delay or patient issues.Surgery was completed successfully.Item has been discarded.No additional information is available.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history review : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: PIN TRL LNR NEUT 48ODX28ID
• Type of Device: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11562797
• MDR Text Key: 242066234
• Report Number: 1818910-2021-05983
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295100195
• UDI-Public: 10603295100195
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2218-28-048
• Device Catalogue Number: 221828048
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1