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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problems Joint Dislocation (2374); No Code Available (3191)
Event Date 08/21/2009
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, "ultra-short anatomic uncemented femoral stem and ceramic-on-ceramic bearing in patients with idiopathic or ethanol-induced femoral head osteonecrosis" written by young-hoo kim, md and jang-won park, md published by the journal of arthroplasty accepted by publisher 21 august 2009 was reviewed. The article's purpose was "to evaluate the long-term clinical outcomes using validated scoring instruments; radiographic results; computed tomography (ct) scan results to determine osteolysis; dual-energy x-ray absorptiometry (dexa) scanning results to determine bone remodeling; complication rates; revision rate and osteolysis; and survivorship of the femoral stem in patients with idiopathic or ethanol-induced femoral head osteonecrosis. " data was compiled from 256 patients (335 hips) including 140 men and 116 women with an average age at the time of surgery of 49. 8 (range 20-63 years). All implants were depuy products. The article does not provide which platforms of cups were associated with specific adverse events. It is noted that a radiographic image is provided for a 45 year old man as an example of well fixated implants. The image notes some calcar resportion but "bone stock is well preserved without stress-shielding-related osteopenia. " depuy products utilized: duraloc and pinnacle cups, proxima stems, coc bearings. Adverse events: clicking or squeaking sounds (interventions unknown), dislocations (treated by closed reductions and revision), femoral loosening (treated by revision), cup loosening (treated by revision), mispositioned cups and mispositioned stems (article reports they were radiographic detections but not revised), femoral fx post op (radiographically discovered after a fall and treated with orif), pain associated with loose stem along with difficulty walking.
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
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
1210 ward avenue
west chester, PA 19380-0988
6107428552
MDR Report Key9466673
MDR Text Key185518692
Report Number1818910-2019-120568
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2019
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 Received01/29/2020
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 Treatment Data
Date Received: 12/13/2019 Patient Sequence Number: 1
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