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U.S. Department of Health and Human Services

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

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DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD Back to Search Results
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).
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
LEEDS MFG & MATERIAL WAREHOUSE
st anthonys road
leeds LS11 8DT
UK LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10274445
MDR Text Key205724703
Report Number1818910-2020-15868
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
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 Received07/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/15/2020 Patient Sequence Number: 1
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