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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL HEAD METAL ASR METAL FEMORAL HEAD

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DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL HEAD METAL ASR METAL FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD METAL ASR
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Patient Problems Wound Dehiscence (1154); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Scar Tissue (2060); Dizziness (2194); Distress (2329); Ambulation Difficulties (2544); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial reporter occupation: lawyer. (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
Asr resurfacing litigation records received. After review of records, the plaintiff alleges pain, loss of balance, difficulty in walking, upset stomach, metallosis, tissue dehiscence, tissue necrosis, bone necrosis, hypertrophic scarring, antalgia, lumbar strain, dizziness, chronic fatigue, chronic pain, severe emotional and/or psychological distress relating to the pain and suffering and elevated metalions. Doi: (b)(6) 2009. Dor: none reported. Unknown affected side.
 
Manufacturer Narrative
(b)(4). Initial reporter occupation: lawyer. (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
Asr resurfacing litigation records received. After review of records, the plaintiff alleges pain, loss of balance, difficulty in walking, upset stomach, metallosis, tissue dehiscence, tissue necrosis, bone necrosis, hypertrophic scarring, antalgia, lumbar strain, dizziness, chronic fatigue, chronic pain, severe emotional and/or psychological distress relating to the pain and suffering and elevated metalions. Doi: (b)(6) 2009. Dor: none reported. Unknown affected side.
 
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Brand NameUNK HIP FEMORAL HEAD METAL ASR
Type of DeviceMETAL FEMORAL HEAD
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13619012
MDR Text Key286240059
Report Number1818910-2022-03714
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K980513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 02/28/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD METAL ASR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/24/2009
Is the Device Single Use? Yes
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: 02/28/2022 Patient Sequence Number: 1
Treatment
UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR
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