MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP IMPLANT

Catalog Number UNK HIP

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Laxity (4526)

Event Date 09/09/2020

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed ogonda l, cassidy rs, beverland de.A conservative approach to dislocation following total hip arthroplasty: a review of 8606 hips.Hip int.2020 sep 9:1120700020959062.Doi: 10.1177/1120700020959062.Epub ahead of print.Pmid: 32905705.Objective and methods: the purpose of this study is to present the rates of dislocation after 8606 primary tha posterior approach procedures and propose a simple algorithm for the management of this often-challenging problem.All procedures were performed between january 1998 and november 2017 and all information was pulled from acp database.All dislocations were first treated conservatively with a variety of interventions.Recurrent dislocations were treated with plad devices or revision surgeries.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: depuy combinations used in the thas: duraloc cup paired with competitor custom femoral stem pinnacle cup/cemented c-stem pinnacle cup/corail stem 138 reverse hybrid thas: cemented charnley elite cups/ stems unknown all articulations: head was either cocr or ceramic and liners were ceramic or poly.Posterior lip augmentation devices (plad) utilized to treat dislocation in 6 patients the cement utilized in the study is unknown.The authors do not provide information that identifies which type of liner/head configurations were involved in the adverse events.As such, the adverse events will be captured as unknown head and unknown liner adverse event(s) and provided interventions associated with depuy devices: 6 disassociations of the duraloc cup/unk liner due to incomplete deployment of the locking mechanism- treated with revision of the liner.218 dislocations treated as follows: 35 treated with hip spica.6 (5 charnley cups, i unk cup/liner) treated with surgical implantation of plad device.4 treated with abduction brace.14 treated with a liner exchange.68 treated with conversion to constrained liner.126 treated with closed reduction.5 revisions of liner and head.1 plad device revised to constrained liner.

Manufacturer Narrative

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

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.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN HIP IMPLANT
• Type of Device: HIP IMPLANT
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13732512
• MDR Text Key: 289259288
• Report Number: 1818910-2022-04506
• Device Sequence Number: 1
• Product Code: KWY
• 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,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• 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