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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR 300 SPIKED CUP SIZE 54 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY INTERNATIONAL LTD - 8010379 ASR 300 SPIKED CUP SIZE 54 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 999830754
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/29/2021
Event Type  Injury  
Event Description
Asr medical record received. After review of medical record, patient was revised due to local adverse tissue reaction secondary to metallosis. Patient had elevated metal ion levels and experienced pain. Revision notes stated that a dark tea-colored thin synovial fluid was encountered. There was small amount of trunnionosis at the base of the trunnion. The acetabular component was noted to have a step-off on the inner diameter resulting in a very sharp edge. Cup was removed with a very minimal bone loss. Bone scan of the bilateral hips done (b)(6) 2021 stated increased periprosthetic tracer uptake greatest along the proximal femoral component at the greater trochanter to lesser trochanter, there is possible hardware loosening. Mri of left hip last (b)(6) 2021 stated that there is no fracture or definite loosening seen. There maybe periprosthetic effusion noted. Laboratory result last (b)(6) 2021 for chromium was 3ng/ml and cobalt was 6. 9ng/ml. Doi: (b)(6) 2009; dor: (b)(6) 2021 (left hip).
 
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter occupation: lawyer. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NameASR 300 SPIKED CUP SIZE 54
Type of DeviceASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
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 Key13453591
MDR Text Key285070450
Report Number1818910-2022-02301
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 Other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 02/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2013
Device Catalogue Number999830754
Device Lot Number2743863
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/24/2008
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: 02/04/2022 Patient Sequence Number: 1
Treatment
ADAPTER SLEEVES 12/14 +8; ASR UNI FEMORAL IMPL SIZE 47; SUMMIT DUOFIX TAP SZ6 HI OFF
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