MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Laxity (4526)

Event Date 04/08/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4) d4: the device catalog number is unknown; therefore, udi is unavailable.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 on (b)(6) 2024 tabs on the poly liner failed, and it spun out.There was wear on both the poly and the ceramic head, possibly from impingement.Both of the implants were back to depuy.Doi: on (b)(6) 2021 , dor: on (b)(6) 2024 , affected side: right hip.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: an analysis of the product could not be performed, since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed, as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected and distributed to approved specifications.Additional complaint information, monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19115925
• MDR Text Key: 340274485
• Report Number: 1818910-2024-08380
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 36IDX52OD; DELTA CER HEAD 12/14 36MM +1.5
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 107 KG