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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problems Use of Device Problem (1670); Osseointegration Problem (3003)
Patient Problems Ossification (1428); Foreign Body Reaction (1868); Bone Fracture(s) (1870); Pain (1994); Inadequate Osseointegration (2646); Joint Laxity (4526); Muscle/Tendon Damage (4532); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/03/2019
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.
 
Event Description
Literature article entitled, ¿zirconia phase transformation in zirconia-toughened alumina ceramic femoral heads: an implant retrieval analysis¿ by thu m. Nguyen, ms, et al, published by the journal of arthroplasty, volume 34, issue 12, december 2019, pages 3094-3098, was reviewed. The study examined the effects of in vivo and artificially-aged phase changes on the burst strength of zirconia-toughened alumina ceramic femoral heads. Twenty-eight zirconium composite alumina ceramic heads were retrieved during revisions, involving four different manufacturers, three different diameters (3 were 28 mm in diameter, 9 were 32 mm, and 16 were 36 mm). It was also noted that other products also revised, affecting four different manufacturers: regarding depuy, there was 1 marathon xlpe and 1 altrx xlpe and 1 non-xlpe polyethylene liner, and 1 tri-lock stem and 1 srom stem. This suggests that there were possibly five ceramic femoral heads from depuy revised, of the twenty-eight total. The following reasons for revision and the number of associated femoral heads retrieved was provided by the authors: loosening: 8, altr: 3, infection: 3, dislocation: 1, fracture: 4, malpositioning: 1, abductor tear: 1, heterotopic ossification: 1, leg length discrepancy: 1, pain: 1, unknown: 4. No other details were provided, nor was information provided that associated manufacturers with the various reasons for revision. Additionally, authors reported that an unspecified number of retrieved femoral heads had metallic scoring, indicative of impingement of the femoral head with the edge of the titanium acetabular cup. Results: although showing evidence of phase change, the heads achieved a burst load far above the 46 kn food and drug administration acceptance criterion, with 3 having burst strengths exceeding 100kn. The study showed that phase transformation occurs in vivo in ceramic composite femoral heads, but the amount transformed does not increase with the length of time the head are implanted. The effect upon burst strength of the retrieved heads is negligible. Impacted products: 1 unknown trilock stem, 1 unknown s-rom stem, 1 unknown s-rom augment, 1 unknown marathon xlpe liner, 1 unknown altrx liner, 1 unknown polyethylene liner, 5 unknown delta ceramic femoral heads.
 
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Brand NameUNKNOWN HIP FEMORAL STEM
Type of DeviceHIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS 1818910
700 orthopaedic dr
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11114400
MDR Text Key225061136
Report Number1818910-2021-00151
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP FEMORAL STEM
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 Received02/02/2021
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: 01/04/2021 Patient Sequence Number: 1
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