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

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pulmonary Embolism (1498); Unspecified Infection (1930); Joint Dislocation (2374); No Code Available (3191)

Event Date 08/31/2004

Event Type  Injury  

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

The literature article entitled, "comparison between triple-tapered and double-tapered cemented femoral stems in total hip arthroplasty" written by eugene t.Ek, mb, bs (hons), and peter f.M.Choong, mbbs, md, fracs, faortha published by the journal of arthroplasty vol.20 no.1 2005 accepted by publisher on 31 august 2004 was reviewed.The article's purpose was to compare the early clinical and radiological results between c-stem and a non depuy stem.Both are cemented monoblock stem.Data was compiled from 405 total hips and 391 patients receiving these implants between (b)(6) 1998 and (b)(6) 2002.Depuy cement was utilized in all cases.Depuy products utilized: monoblock c-stem with cement restrictor, duraloc cup, elite plus cup, liner & locking rings, bone cement.Adverse events associated with c-stem group: pe (treated with antigcoagulants), dislocations (treated with closed reduction and outpatient physiotherapy), periprosthetic femoral fracture (associated with a fall from ladder and treated with revision), infection (treated with iv antibiotics and multiple washouts and debridements).Specific identification of devices explanted in revision cases not provided.Adverse events associated from both groups that can be associated with cement as it is used in both groups: pe (treated with anticoagulants), dvt (treated with anticoagulants), infection (treated with revision/iv antibiotics and debridements) specific identification of devices explanted in revision cases not provided.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: 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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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
• MDR Report Key: 9316755
• MDR Text Key: 182458303
• Report Number: 1818910-2019-112943
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/13/2019
• Supplement Dates Manufacturer Received: 01/10/2020
• Supplement Dates FDA Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention