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

Catalog Number UNK HIP

Device Problem Loss of Osseointegration (2408)

Patient Problems Inadequate Osseointegration (2646); Not Applicable (3189); No Code Available (3191)

Event Date 12/01/2017

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.

Manufacturer Narrative

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

Event Description

"literature article entitled, ¿inferomedial hip center decreases failure rates in cementless total hip arthroplasty for crowe ii and iii hip dysplasia¿ by chad d.Watts, md, et al, published by the journal of arthroplasty (2018), vol.33, pp.2177-2181, was reviewed.In this study, the authors sought to evaluate the outcomes of cementless acetabular components used in patients with crowe ii and iii dysplasia, and to compare outcomes between cups placed within vs outside of an ¿anatomic¿ zone.This retrospective study reviewed 88 hips with a primary diagnosis of ddh implanted with both competitor and depuy thas between 1988 and 2014.The manufacturer of the stems used was not provided.This complaint will capture the adverse events associated with depuy products.Results: the revisions and adverse events associated with competitor products are excluded from this complaint.1 trilock and 1 duraloc cup were revised due to aseptic loosening of the implant to bone interface.There were an unknown number of acetabular screws revised as well.1 duraloc polyethylene liner and depuy cocr femoral head were revised due to dislocation secondary to polyethylene liner wear.Impacted products: 2 cups: implant loosening.1 acetabular screw: implant loosening.1 polyethylene liner: implant dislocation, implant bearing wear.1 femoral head: implant dislocation.Harms and symptoms: surgical intervention, medical device removal, inadequate osseointegration, joint dislocation.".

• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9628662
• MDR Text Key: 184731503
• Report Number: 1818910-2020-02860
• Device Sequence Number: 1
• Product Code: KWA
• 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,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• 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: 03/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention