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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 14/16 LG TAPER M HEAD 36MM+5; LARGE TAPER FEMORAL HEADS : HIP METAL FEMORAL HEADS
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DEPUY ORTHOPAEDICS INC US 14/16 LG TAPER M HEAD 36MM+5; LARGE TAPER FEMORAL HEADS : HIP METAL FEMORAL HEADS Back to Search Results
Model Number 1018-36-505
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 07/16/2021
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 dislocation.No surgical delay.Doi: (b)(6) 2021, dor: (b)(6) 2021, left hip.
 
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.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
14/16 LG TAPER M HEAD 36MM+5
Common Device Name
LARGE TAPER FEMORAL HEADS : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12289036
Report Number1818910-2021-17348
Device Sequence Number11473243
Product Code LPH
UDI-Device Identifier10603295001386
UDI-Public10603295001386
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K120599
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 07/16/2021
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? Yes
Operator of Device Health Professional
Device Model Number1018-36-505
Device Catalogue Number101836505
Device Lot Number9461815
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/16/2021
Supplement Date Received by Manufacturer08/25/2021
Initial Report FDA Received Date08/06/2021
Supplement Report FDA Received Date08/26/2021
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
14/16 LG TAPER M HEAD 36MM+5; DUR DYNAMIC LOCK RING 62 OR 74; DUR MAR +4 NEUT LNR 36X62; 14/16 LG TAPER M HEAD 36MM+5; DUR DYNAMIC LOCK RING 62 OR 74; DUR MAR +4 NEUT LNR 36X62
Outcome Attributed to Adverse Event Required Intervention;
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