MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 44X28 GRY; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Model Number 1035-44-000

Device Problem Difficult to Insert (1316)

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

Event Date 03/30/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # pc-(b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the liner didn't lock properly inside the shell and there was more motion that expected inside the shell.

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.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary; the device associated with this report was returned to depuy synthes for evaluation.Examination of the device was not able to confirm the complaint.No unintended motion of the liner inside the metal shell was found during inspection.Reported condition was not able to be replicated.Additionally, a dimensional inspection was performed and device met specifications.No visual defects were observed on the implant.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot; a search of the depuy nonconformance (nc) quality system found no related nc¿s associated with this product/lot combination issue.H3.

• Brand Name: SELF CENT HIP 44X28 GRY
• Type of Device: HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16748430
• MDR Text Key: 313725221
• Report Number: 1818910-2023-08033
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003342
• UDI-Public: 10603295003342
• Combination Product (y/n): N
• PMA/PMN Number: K812672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2023

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 Model Number: 1035-44-000
• Device Catalogue Number: 103544000
• Device Lot Number: J8571J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/15/2023
• Supplement Dates Manufacturer Received: 04/25/2023; 06/02/2023
• Supplement Dates FDA Received: 04/26/2023; 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1