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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 11/13 28MM +3; S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS
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DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 11/13 28MM +3; S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Model Number 1365-28-220
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 06/09/2021
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.Investigation summary: no device associated with this report was received for examination.Examination of the provided x-ray images does not find a dislocation event depicted.The review does find the acetabular cup is mispositioned, having both more abduction and version angle than what would be recommended by depuy.This may have been a contributing factor in the reported dislocation event.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.
 
Event or Problem Description
It was reported that patients hip dislocated post op, next day cup was removed and version was changed.New screws new liner were implanted.Doi: (b)(6) 2021; dor: (b)(6) 2021; unknown hip.
 
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Brand Name
DELTA CER HEAD 11/13 28MM +3
Common Device Name
S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12120808
Report Number1818910-2021-14303
Device Sequence Number17085746
Product Code LZO
UDI-Device Identifier10603295033257
UDI-Public10603295033257
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P070026
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
Report Date (Section B) 06/09/2021
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 Number1365-28-220
Device Catalogue Number136528220
Device Lot Number8955084
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/09/2021
Initial Report FDA Received Date07/06/2021
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
ALTRX NEUT 28IDX44OD; DELTA CER HEAD 11/13 28MM +3; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; UNKNOWN HIP ACETABULAR CUP
Outcome Attributed to Adverse Event Required Intervention;
Patient Age18 YR
Patient Weight59
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