MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Loss of or Failure to Bond (1068); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Ossification (1428); Foreign Body Reaction (1868); Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Osteolysis (2377); Test Result (2695); No Code Available (3191)

Event Date 01/06/2020

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, "hip resurfacing arthroplasty for osteonecrosis of the femoral head: implant-specific outcomes and risk factors for failure" written by chan-woo park, seung-jae lim, joo-hwan kim, and youn-soo park published by the journal of orthopaedic translation made available online on 6 january 2020 was reviewed.The article's purpose was to investigate implant-specific outcomes and to analyze risk factors for failures of hip resurfacing arthroplasty (hra) in patients with osteonecrosis of the femoral head.Data was compiled from 202 hips (166 patients) implanted between september 2003 and october 2013 with depuy and non-depuy implants.Cement manufacturer is not identified.It is noted that 99 implants were depuy asr and the remaining were non-depuy.A total 17 asr implants required revisions.Figure 2 provides radiographic images with caption description of (b)(6) year old man prior to asr implantation and then requiring revision due to progressive groin pain 6 years postoperatively.Intraoperative findings were loose femoral implant followed by conversion to cementless total hip arthroplasty.Depuy products: asr cup, asr femoral head.Adverse events: figure 2 caption description (treated by revision) armd (adverse reaction to metal debris treated by revision) femoral neck fracture (treated by revision) femoral implant loosening (interface unknown and treated by revision) acetabular loosening (treated by revision) unexplained pain (treated by revision) infection (treated by revision) elevated cobalt and chromium levels (treated by revision) radiographic detection of osteolytic lesions, indentation, bony spur, neck narrowing and hetertopic ossification (treated by revision).

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.H10 additional narrative: added: h6 (patient).Corrected: h6 (device).

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10274445
• MDR Text Key: 205724703
• Report Number: 1818910-2020-15868
• 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: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention