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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT COLLAR SIZE 13 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

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DEPUY FRANCE SAS - 3003895575 CORAIL AMT COLLAR SIZE 13 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM Back to Search Results
Model Number 3L92503
Device Problems Fracture (1260); Naturally Worn (2988)
Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Ambulation Difficulties (2544); Not Applicable (3189); No Code Available (3191)
Event Date 06/12/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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
It was reported that the corail stem. Trunnion broke off the body of the stem. Doi: (b)(6) 2014, dor: (b)(6) 2020, affected side: unknown.
 
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Brand NameCORAIL AMT COLLAR SIZE 13
Type of DeviceCORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR 69801
Manufacturer (Section G)
DEPUY FRANCE SAS 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR 69801
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10200188
MDR Text Key196586976
Report Number1818910-2020-14499
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,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Model Number3L92503
Device Catalogue Number3L92503
Device Lot Number5231322
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2014
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: 06/26/2020 Patient Sequence Number: 1
Treatment
UNKNOWN HIP FEMORAL HEAD
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