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 Pulmonary Embolism (1498); Pain (1994); Joint Dislocation (2374); No Code Available (3191)

Event Date 11/21/2019

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, "review of total hip arthroplasty in patients younger than 30 years: mid- to long-term results" written by yuvraj agrawal, robert m kerry, ian stockley, and andrew j hamer published by hip international accepted by publisher on 21 november 2019 was reviewed.The article's purpose was to report on results of total hip arthroplasties less than 30 years by examining clinical, radiological and functional outcomes in a high-volume specialist arthroplasty unit.Data was compiled from 78 patients who underwent 101 primary hip arthroplasties with age range of 16-30 years.Table 2 provides a list of depuy and non-depuy components including uncemented, cemented and hip surfacing.Cement manufacturer is not identified.Article reports 19 of these patients (25 hips) underwent revision for a variety different reasons listed in table 3 but does not identify which adverse events are associated with which specific products.Bearing surfaces were either metal-on-poly or ceramic-on-ceramic uncemented depuy products: duraloc cup, pinnacle cup, corail stem, srom stem, liner (assumed), head (assumed) cemented depuy products: elite plus cup, c-stem, charnley stem, asr resurfacing cup, asr resurfacing head listed reasons for revisions: aseptic loosening (component or interface not specified) liner wear.Pain.Peri-prosthetic fracture (anatomical location not provided).Other adverse events: pulmonary embolus (treated in consultation with hematologists).Dislocation (no information regarding treatment).

Manufacturer 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.

• 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
• MDR Report Key: 10158711
• MDR Text Key: 195286519
• Report Number: 1818910-2020-13857
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• 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
• Date Manufacturer Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention