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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 CORAIL HA W/O COLLAR S12 150MM HIP FEMORAL STEM

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DEPUY INT'L LTD. 8010379 CORAIL HA W/O COLLAR S12 150MM HIP FEMORAL STEM Back to Search Results
Catalog Number L92512
Device Problem Degraded (1153)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/05/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Doi: (b)(6) 2004: patient received a primary left tha to treat advanced avascular necrosis. The patient received a pinnacle/corail metal-on-metal hip. The procedure was completed without complications. Dor: (b)(6) 2019: patient received a left hip revision to treat dull pain and mri identified metal-on metal reaction. Preoperative testing revealed elevated serum blood heavy metal levels. Upon entering the joint, the surgeon identified and excised black stained synovium. There was no wear or reported defects of the revised femoral head. There was minimal corrosion of the femoral stem trunnion. The corrosion was cleaned, and the well-fixed stem was retained. There was noted corrosion on the metal liner, and it was revised. The well-fixed cup was retained. The patient was revised with a depuy poly liner and ceramic femoral head. The procedure was completed without complications. Doi: (b)(6) 2004. Dor: (b)(6) 2019. Left hip.
 
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Brand NameCORAIL HA W/O COLLAR S12 150MM
Type of DeviceHIP FEMORAL STEM
Manufacturer (Section D)
DEPUY INT'L LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer (Section G)
LEEDS MFG & MATERIAL WAREHOUSE
st anthonys road
leeds LS11 8DT
UK LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13804081
MDR Text Key289073878
Report Number1818910-2022-04910
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042992
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberL92512
Device Lot Number1434963
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/12/2003
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: 03/18/2022 Patient Sequence Number: 1
Treatment
APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +12; PINNACLE 100 ACET CUP 52MM; PINNACLE MTL INS NEUT36IDX52OD
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