MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Ossification (1428); Thrombosis (2100); Joint Dislocation (2374); Post Operative Wound Infection (2446)

Event Type  Injury  

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.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.(b)(4).

Event Description

"literature article abstract entitled, ¿results of acetabular wiremesh and autograft in protrusio acetabuli¿ by g.Figueras coll, et al, published by hip international (2008), vol.18, no.1, pp.23-28, was reviewed.The purpose of this article was to report the author¿s results of 25 acetabular reconstructions performed between 1990 and 2005 with autogenous morselized bone graft and acetabular wiremesh due to acetabular bone stock loss.There were 25 hips included in this study.20 hips were index thas.In the remaining 5 cases, 3 were revisions of competitor prostheses and 2 were revisions of charnley thas including a polyethylene cups cemented with competitor cement, a cementless charnley stem, and a depuy femoral head.The revisions were performed due to aseptic loosening of an unspecified component.Implanted depuy products: all 25 hips included in this study were charnley polyethylene cups cemented with competitor cement, a depuy femoral head, and a cementless charnley stem.Results: 4 deep vein thrombi- treatment unknown 3 postoperative dislocations- treatment unknown 3 cases of superficial wound infections treated with oral antibiotics an unspecified number of radiographically identified asymptomatic heterotopic ossification- no treatment required 1 case of radiolucent lines greater than 2-mm- no treatment required.Captured in this complaint: revision one: 2 charnley stems: implant loosening, inadequate osseointegration, surgical intervention, medical device removal.The charnley cup was implanted with competitor cement.There is insufficient information within the text of the article to attribute the loosening to the cup that cemented with competitor cement.Implants included in this study: charnley stem: no reported product problem.Charnley cup and femoral head: implant dislocation.Patient harms: joint dislocation, infection, extraskeletal ossification.".

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• 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 ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9400870
• MDR Text Key: 185559483
• Report Number: 1818910-2019-119448
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2019
• 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