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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 12 HIP FEMORAL STEM

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DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 12 HIP FEMORAL STEM Back to Search Results
Model Number L20312
Device Problems Fracture (1260); Loss of Osseointegration (2408); Unintended Movement (3026)
Patient Problems Bone Fracture(s) (1870); Pain (1994); Inadequate Osseointegration (2646); Not Applicable (3189); No Code Available (3191)
Event Date 05/30/2020
Event Type  Injury  
Manufacturer Narrative
(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 surgeon believes that the stem fractured inter-op. The patient experienced pain from the beginning and it progressively got worse, up on review of the follow up x-rays the greater had fractured and propagated down the shaft. The stem had also subsided down. Surgeon did a reclaim but we had an issue with the 40 mm neck trial where the bolt that locks the version was stuck in the locked position. This prevented him form doing a final trial before he placed the real proximal body which was an 85 x 40. He decided to move forward with that size but when he relocated the hip it was too tight and long. We ended up removing the 85 body and switching it to a 75. The 85 body was wasted do to the failure of the trial neck. Doi: unknown, dor: (b)(6) 2020, affected site: unknown.
 
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Brand NameCORAIL2 NON COL HO SIZE 12
Type of DeviceHIP 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)
LEEDS MFG & MATERIAL WAREHOUSE
st anthonys road
leeds LS11 8DT
EI LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10146948
MDR Text Key194944521
Report Number1818910-2020-13700
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberL20312
Device Catalogue NumberL20312
Device Lot Number5343152
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2019
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: 06/12/2020 Patient Sequence Number: 1
Treatment
ALTRX NEUT 36IDX54OD; CORAIL2 NON COL HO SIZE 12; DELTA CER HEAD 12/14 36MM +1.5
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