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

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Fracture (1260); Use of Device Problem (1670); Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Unspecified Infection (1930); Pain (1994); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 08/05/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.(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, ¿comparison of the risk of revision in cementless total hip arthroplasty with ceramic-on-ceramic and metal-on-polyethylene bearings¿ by claus varnum, et al, published by acta orthopaedica (2015), vol.86, vol.4, pp.477-484, was reviewed.The authors compared the 9-year revision risk for cementless coc tha and for cementless metal-on-polyethylene (mop) tha.The data used for this study was retrieved from the danish health registry for the dates january 1, 2002 through september 15, 2009.There were results for both depuy and competitor thas.Depuy products: 63 duraloc option cups using biolox forte articulating surfaces.41 pinnacle cups with biolox delta articulating surfaces.102 corail and 18 s-rom femoral stems.Results: this article does not specify manufacturer with adverse events.This complaint will only capture events associated with coc bearing failures and femoral stems as these were the depuy products identified in the study.9 stem revisions for periprosthetic fracture 22 revisions of head and liner for dislocation 6 total revisions for deep infection 10 revisions for aseptic loosening of the cup 9 total revisions for unspecified pain 2 head and liner revisions for impingement between stem and liner rim due to liner misposition 2 revisions for fracture of both liner and head 3 head and liner revisions for fracture of ceramic head 1 liner revision for fracture of ceramic liner 2 revisions of head and liner due to squeaking of the hip.Captured in this complaint: stem, head, liner, cup, and femoral augment.The authors identify one patient implanted with a depuy tha labeled (b)(6) female.This patient is included in the attached guidance document.Please link patient labeled (b)(6) female to parent pc-000584239.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• 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: 9342891
• MDR Text Key: 183191211
• Report Number: 1818910-2019-114678
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2019
• 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