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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 TOTAL HIP BALL 32MM +5; LARGE TAPER FEMORAL HEADS : HIP METAL FEMORAL HEADS
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DEPUY INTERNATIONAL LTD - 8010379 TOTAL HIP BALL 32MM +5; LARGE TAPER FEMORAL HEADS : HIP METAL FEMORAL HEADS Back to Search Results
Model Number 1014-68-000
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); No Code Available (3191)
Date of Event 06/16/2020
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
The patient was revised due to hip pain.Doi: (b)(6) 2002, dor: (b)(6) 2020, affected site: unknown.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
 
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Brand Name
TOTAL HIP BALL 32MM +5
Common Device Name
LARGE TAPER FEMORAL HEADS : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key10201032
Report Number1818910-2020-14538
Device Sequence Number1073420
Product Code JDI
UDI-Device Identifier10603295001263
UDI-Public10603295001263
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K880269
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2002
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number1014-68-000
Device Catalogue Number101468000
Device Lot NumberV37AX1008
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/16/2020
Supplement Date Received by Manufacturer08/11/2020
Initial Report FDA Received Date06/26/2020
Supplement Report FDA Received Date08/11/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
APEX HOLE ELIM POSITIVE STOP; DUR DYNAMIC LOCK RING 56 OR 68; DURALOC SECTOR SERIES 56OD; ENDURON NEUT 56 OR 68ODX32ID; APEX HOLE ELIM POSITIVE STOP; DUR DYNAMIC LOCK RING 56 OR 68; DURALOC SECTOR SERIES 56OD; ENDURON NEUT 56 OR 68ODX32ID
Outcome Attributed to Adverse Event Required Intervention;
Patient Age66 YR
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