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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HIP BALL BIOLOX 32 +1 12/14 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

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DEPUY INTERNATIONAL LTD - 8010379 HIP BALL BIOLOX 32 +1 12/14 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Catalog Number 9111131
Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Discomfort (2330); Joint Dislocation (2374)
Event Date 02/22/2021
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

Customer is reporting a disassociation of inlay from cup. Head was reaming at the inner part of the cup. Surgical notes indicate the patient underwent a primary tha on (b)(6) 2019 with depuy implants. Multiple physical therapy notes also included after the primary surgery which show successful rehabilitation. On (b)(6) 2021, the patient dislocated with "luxation of the head in the cup with inlay dislocation. " metallosis was found as well as a tilted inlay for unknown reason.

 
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Brand NameHIP BALL BIOLOX 32 +1 12/14
Type of DeviceARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11567799
MDR Text Key242187809
Report Number1818910-2021-06049
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/10/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number9111131
Device LOT Number8758641
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/15/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/26/2018
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: 03/25/2021 Patient Sequence Number: 1
Treatment
APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 12; HIP BALL BIOLOX 32 +1 12/14; PINN MAR NEUT 32IDX54OD; PINNACLE 100 ACET CUP 54MM
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