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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP ACETABULAR CUP ASR

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DEPUY INTERNATIONAL LTD - 8010379 UNK HIP ACETABULAR CUP ASR Back to Search Results
Catalog Number UNK HIP ACETABULAR CUP ASR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Osteolysis (2377)
Event Date 10/28/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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
This complaint is from a literature source. The following literature cite has been reviewed eachempati kk, dannana cs, apsingi s, ponnala vk, boyapati g, parameswaran a. Trunnion fracture of femoral prosthesis following a large metal-on-metal uncemented total hip arthroplasty: a case report. Arthroplasty. 2020 oct 28;2(1):32. Doi: 10. 1186/s42836-020-00055-3. Pmid: 35236457; pmcid: pmc8796406. Adverse event(s) and provided interventions associated with depuy devices: a (b)(6) male patient with juvenile idiopathic arthropathy presented to us with sudden onset pain secondary to a fracture of the trunnion of his left tha, with no history of trauma. Upon entering the joint, the surgeon identified and debrided periarticular metallosis. The stem was fractured at the trunnion and there was evidence of corrosion at the head/neck junction. The cup was well-fixed and revised, there was evidence of osteolysis in the acetabulum. There was no reported product problem with the revised asr xl femoral augment. The patient was revised with competitor products. The procedure was completed without complications. Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: asr xl 54 mm acetabular cup, 47 mm + 6 neck offset asr xl femoral component, asr xl femoral segment, size 14 a+ aml stem.
 
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Brand NameUNK HIP ACETABULAR CUP ASR
Type of DeviceHIP ACETABULAR CUP
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key13995338
MDR Text Key288493822
Report Number1818910-2022-06053
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR CUP ASR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/14/2022
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
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 04/04/2022 Patient Sequence Number: 1
Treatment
UNKNOWN HIP FEMORAL AUGMENT.; UNKNOWN HIP FEMORAL HEAD.; UNKNOWN HIP FEMORAL STEM.
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