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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 36MM +5.0 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

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DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 36MM +5.0 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Model Number 1365-36-720
Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problems Fall (1848); Pain (1994); Joint Dislocation (2374)
Event Date 01/03/2020
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

Pinnacle medical records received. After review of medical records patient was revised to addressed recurrent anterior superior dislocation. Prior to revision patient alleges pain, discomfort, dislocation with closed reduction and fall. Clinic reports reported of squeaking. Doi: (b)(6) 2019, dor: (b)(6) 2020, right hip 2nd revision. Please see (b)(4) right hip 1st revision. (b)(4) left hip.

 
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Brand NameDLT TS CER HD 12/14 36MM +5.0
Type of DeviceARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY IRELAND - 9616671
loughbeg, ringaskiddy co
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10991799
MDR Text Key220929093
Report Number1818910-2020-26798
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK071830
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1365-36-720
Device Catalogue Number136536720
Device LOT Number9246269
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/08/2019
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: 12/11/2020 Patient Sequence Number: 1
Treatment
ALTRX +4 10D 36IDX54OD; DLT TS CER HD 12/14 36MM +5.0
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