MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Use of Device Problem (1670); Malposition of Device (2616); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2011

Event Type  malfunction  

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.(b)(4).

Event Description

"literature article entitled, ¿migration patterns of cementless press fit cups in the presence of stabilizing screws in total hip arthroplasty¿ by c.Zilkens, et al, published by european journal of medical research (2011), vol.16, pp.127-132, was reviewed.The aim of this study was to evaluate the initial acetabular implant stability and late acetabular implant migration in press fit cups combined with screw fixation of the acetabular component in order to answer the question whether screws are necessary for the fixation of the acetabular component in cementless primary total hip arthroplasty.The authors do not identify the femoral components used within this study performed between 2001 and 2007.The cups and liners used were depuy and competitor products.Implanted depuy products: 33 duraloc cups and polyethylene liners.The cups were secured with an unknown number of acetabular screws.Results: the authors do not identify the results by component manufacturer.The actual number of impacted depuy products is unknown.1 cup, screw, and liner revision due to aseptic loosening of the cup.Intraoperative findings revealed cup migration secondary to the loosened cup.There was no reported product problem with the acetabular liner.1 liner exchange due to recurrent dislocation.The manufacturer of the head is unknown and therefore not included in this complaint.1 liner revision due to excessive wear.1 superficial infection treated with surgical incision and debridement.No revision surgery was required.There were an unknown number of radiographically identified asymptomatic radiolucent lines that required no intervention.23 cases of radiographically identified, asymptomatic osteolytic lesions.No treatment or intervention required.There were an unknown number of mispositioned and migrated acetabular cups and screws.There were no patient consequences and no intervention was required.Captured in this complaint: duraloc cup and screw: implant loosening and migration.Infection, surgical intervention, inadequate osseointegration, and medical device removal.Poly liner: bearing wear and implant dislocation.Medical device removal, surgical intervention, joint dislocation, osteolysis, and infection.Duraloc cup and screw: implant migration and malposition.No patient consequences, no clinical signs, symptoms, or conditions.".

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # : (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9587779
• MDR Text Key: 189216944
• Report Number: 1818910-2020-01807
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1