MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER POLY

Catalog Number UNK HIP ACETABULAR LINER POLY

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Joint Dislocation (2374); Joint Laxity (4526); Insufficient Information (4580)

Event Date 05/27/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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

This complaint is from a literature source.The following literature cite has been reviewed white-gibson a, sheridan ga, ghetti ac, keogh p, kenny p, cashman jp.The utility of cemented femoral stems in modern tha: a 10-year comparative analysis of the charnley and exeter stems.Ir j med sci.2024 feb;193(1):251-255.Doi: 10.1007/s11845-023-03381-y.Epub 2023 may 27.Pmid: 37243843; pmcid: pmc10810030.Objective and methods: the primary aim of this study is to assess the 10-year outcomes of cemented stems comparing 956 charnley and 395 competitor stems revised between january 2005 and june 2008 with prospectively collected data from the irish national joint registry.The secondary aim was to assess the main predictors of revision with these two common cemented femoral stems.The authors note that most patients had metal on polyethylene articulations.The manufacturer of femoral head and acetabular liner associated with the charnley stem is not specified but assumed to be depuy.The authors do not provide the manufacturer of the cement utilized with the stems.This complaint will capture the results associated with the depuy charnley construct.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: charnley femoral stem, unknown metal femoral head, unknown poly acetabular liner adverse event(s) and provided interventions associated with depuy devices: 6 revisions for infection 3 revisions for instability/dislocation 2 revisions for aseptic loosening of the stem at an unknown interface 2 revisions for unspecified ¿other¿ reasons.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.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.If additional information is made available, the investigation will be updated as applicable.Device history lot: the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: UNK HIP ACETABULAR LINER POLY
• Type of Device: ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 19193106
• MDR Text Key: 341240953
• Report Number: 1818910-2024-09243
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER POLY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/08/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention