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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL2 NON COL HO SIZE 9 HIP FEMORAL STEM

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DEPUY FRANCE SAS 3003895575 CORAIL2 NON COL HO SIZE 9 HIP FEMORAL STEM Back to Search Results
Model Number L20309
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/25/2018
Event Type  Injury  
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.
 
Event Description
Pc was created to captured the left hip. On (b)(6) 2011, the patient had a left total hip arthroplasty to address left hip arthroplasty to address left hip arthritis. Depuy components were used during this procedure. No complications were noted during the procedure. (part/lot page 250 of 302). On (b)(6) 2018, the patient had a revision left total hip arthroplasty, to address failed left total hip arthroplasty, wear of articular bearing surface, and elevated of serum cobalt and chromium. The ceramic femoral head and metal liner were revised. Depuy components were implanted during this procedure along with competitor cement. The surgeon reports that due to excessive acetabular anteversion, the patient has developed elevations of cobalt and chromium. The patient reported experiencing subluxation. Prior to surgery the patient had an aspiration, which was noted to suggest infection, yet a repeat aspiration negated that diagnosis. During the surgery, the surgeon observed black synovial fluid (which was later diagnosed as metallosis). A single screw was left in place as the head had stripped, the remaining screws were removed. The cup was left insitu as the surgeon felt they could correct the misposition with a liner. The surgeon then roughed up the acetabular cup with a saw blade and created several notches in the posterior surface of the new poly liner for competitor cement placement. (sticker sheet page 261 of 302). Doi: (b)(6) 2011 dor: (b)(6) 2018 left hip. (b)(4) for right hip.
 
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Brand NameCORAIL2 NON COL HO SIZE 9
Type of DeviceHIP FEMORAL STEM
Manufacturer (Section D)
DEPUY FRANCE SAS 3003895575
7 allee irene joliot curie
b.p. 256
st. priest cedex 69801
FR 69801
Manufacturer (Section G)
DEPUY FRANCE SAS 3003895575
7 allee irene joliot curie
b.p. 256
st. priest cedex 69801
FR 69801
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13290656
MDR Text Key285696333
Report Number1818910-2022-01186
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/01/2013
Device Model NumberL20309
Device Catalogue NumberL20309
Device Lot Number2707441
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/08/2008
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: 01/19/2022 Patient Sequence Number: 1
Treatment
CORAIL2 NON COL HO SIZE 9; DELTA CER HEAD 12/14 36MM +1.5; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 52MM; PINNACLE MTL INS NEUT36IDX52OD
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