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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Tissue Damage (2104); Test Result (2695); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number. The correction/removal reporting number listed applies to the corresponding product code sold domestically. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
A literature article was received, entitled "high prevalence of adverse reactions to metal debris in small-headed asr hips¿, by aleksi reito md, et. Al, published in clin orthop relat res (2013) 471:2954¿2961, and was reviewed by clinician for mdr reportability. The authors sought to determine the prevalence of adverse reactions to metal debris among patients who received small-headed (less than 50 mm diameter) articular surface replacement (asr) prostheses in hip resurfacing procedures, or the asr xl prostheses during thas, and identify the risk factors for adverse reactions to metal debris and if they are differ between hip resurfacing replacements compared to thas. At follow-up, of 482 hips,162 hips (34%) have been revised. The majority (85%) were revised owing to causes related to adverse reactions to metal debris. The 7-year survivorship was 51% for the asr hip resurfacing cohort and 38%for the asr xl tha cohort, respectively. Reduced cup coverage was an independent risk factor for adverse reactions to metal debris in both cohorts. High preoperative rom, use of the corail stem, and female gender were associated with an increased risk of adverse reactions to metal debris only in patients undergoing tha. Causes of revisions in asr resurfacing: number affected: adverse reaction to metal debris: 42. Infection: 1. Aseptic loosening cup: 3. Aseptic loosening stem: 0. Avascular necrosis: 1. Periprosthetic fracture (unspecified bone): 2. Pain (without adverse reaction to metal debris): 2. Causes of revisions in asr xl total hip: number affected: adverse reaction to metal debris: 42. Infection: 1. Aseptic loosening cup: 3. Aseptic loosening stem: 1. Avascular necrosis: 1. Periprosthetic fracture (unspecified bone): 2. Pain (without adverse reaction to metal debris): 2. Additionally, it was reported that pseudotumors were identified in 42 hips by cross sectional imaging. Whole blood chromium and/or cobalt level exceeded 7 ppb in 30 (18%) patients who had unilateral hip resurfacing and in 115 (37%) patients who had unilateral tha.
 
Manufacturer Narrative
(b)(4).
 
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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 8 DT
UK LS11 8 DT
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6107428552
MDR Report Key8749472
MDR Text Key149679042
Report Number1818910-2019-97252
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 06/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received08/28/2019
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
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 07/01/2019 Patient Sequence Number: 1
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