MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP ACETABULAR CUP OGEE; POLY ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP OGEE

Device Problems Loss of or Failure to Bond (1068); Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Joint Dislocation (2374); Post Operative Wound Infection (2446); Thrombosis/Thrombus (4440)

Event Date 06/01/2019

Event Type  Injury  

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This complaint is from a literature source.The following literature cite has been kiran m, yadav a, johnstone l, mcleod g, jariwala a.Comparative analysis of different total hip replacement implants used in a single health region of the united kingdom - minimum 15 years follow-up.Acta orthop belg.2019 jun;85(2):192-198.Pmid: 31315009.Objective and methods: the purpose of this article is to describe the functional and radiological results at minimum 15 years follow up of four groups of total hip replacement (thr) implants in 876 hips implanted between january 1995 and december 1999.Of the 876 hips, 387 were depuy charnley cemented stems with ogee all-poly cups.The remaining implants were competitor thas.The manufacturer of the cement utilized was not specified.This complaint will capture the events associated with the depuy charnley hips.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: cemented depuy charnley monopolar stem and depuy charnley ogee all-poly cup.Adverse event(s) and provided interventions associated with depuy devices: 12 dislocations, 12 superficial infections, 11 dvt, 5 reports aseptic loosening of an unknown device, 1 deep infection, 2 periprosthetic femoral fractures.The authors do not specify the treatment for the complications associated with the charnley thas.At the final 15 years follow-up, the charnley tha had a 98.5% survivorship, indicating that at least 6 of the charnley thas were revised.

• Brand Name: UNK HIP ACETABULAR CUP OGEE
• Type of Device: POLY ACETABULAR CUP
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• 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: 15012810
• MDR Text Key: 295862241
• Report Number: 1818910-2022-13009
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/14/2022

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 OGEE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/14/2022
• 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