MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 DPS TRL HD M 32 +5; HIP INSTRUMENT - TRIAL HEAD

Catalog Number 483132050

Device Problem Device-Device Incompatibility (2919)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that the implants and trial heads did not correlate.Trial heads were stable and implants were not.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

There was a surgical delay of a few minutes.No adverse reaction to the patient.All parts and lots have been reported.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : it was reported that the implants and trial heads did not correlate.Trial heads were stable and implants were not.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned sample revealed that there were no damage or defect with the dps trl hd m 32 +5.A dimensional inspection was performed for the dps trl hd m 32 +5 and met specifications.A functional test was unable to be performed due to mating devices did not return.The overall complaint was unconfirmed as the observed condition of the dps trl hd m 32 +5 would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing: 103613098 rev 2 feature: outer diameter specification: 31.344 +/-0.127 mm measured dimension: 31.30 mm device used: mitutoyo digimatic caliper a20276546 id# (b)(4).Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information, that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained, that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DPS TRL HD M 32 +5
• Type of Device: HIP INSTRUMENT - TRIAL HEAD
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18778554
• MDR Text Key: 337071512
• Report Number: 1818910-2024-04330
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295515920
• UDI-Public: 10603295515920
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

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
• Device Operator: Health Professional
• Device Catalogue Number: 483132050
• Device Lot Number: AZ496695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 02/29/2024; 03/12/2024; 04/18/2024
• Supplement Dates FDA Received: 03/07/2024; 03/13/2024; 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female