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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); Joint Laxity (4526); Unspecified Tissue Injury (4559); Physical Asymmetry (4573)
Event Date 09/23/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). (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
Pinnacle pfs and medical records received. Pfs alleges pain, sleeping disturbance, discomfort right leg, hip, walking difficulty and instability. Miss out work due to hip pain, surgery and recovery. Plaintiff is seeking compensation for all the injuries and financial losses. After review of the medical records the lab result mri hip reported there was a streak artifact despite metal artifact reduction. There is a mild atrophy of the right iliopsoas and hamstring tendinopathy. Mild degenerative arthrosis of the symphysis pubis and pubalgia. Cobalt and chromium result were below 7 ppb. Doi: (b)(6) 2010; dor: (b)(6) 2019; right hip.
 
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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 IN 69801
FR 69801
Manufacturer (Section G)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex IN 69801
FR 69801
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12309015
MDR Text Key266073338
Report Number1818910-2021-17619
Device Sequence Number1
Product Code KWA
UDI-Device Identifier10603295258032
UDI-Public10603295258032
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192946
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/20/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberL20312
Device Catalogue NumberL20312
Device Lot Number5034142
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2010
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: 08/11/2021 Patient Sequence Number: 1
Treatment
UNK HIP ACETABULAR CUP PINNACLE; UNKNOWN HIP ACETABULAR LINER; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
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