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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 51X28 BRN; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
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DEPUY ORTHOPAEDICS INC US SELF CENT HIP 51X28 BRN; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Model Number 1035-51-000
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes Joint Dislocation (2374); No Code Available (3191)
Date of Event 09/13/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(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
It was reported that the patient dislocated and couldn¿t be reduced.Physician wanted to revise head to make joint more stable.Stem was not fixated si doctor then decided to use a cemented stem.Doi: (b)(6) 2020.Dor: (b)(6) 2020.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.
 
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Brand Name
SELF CENT HIP 51X28 BRN
Common Device Name
HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10580901
Report Number1818910-2020-20846
Device Sequence Number14230594
Product Code KWY
UDI-Device Identifier10603295003410
UDI-Public10603295003410
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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) 09/13/2020
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? Yes
Operator of Device Health Professional
Device Model Number1035-51-000
Device Catalogue Number103551000
Device Lot NumberH68376
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/13/2020
Supplement Date Received by Manufacturer11/04/2020
Initial Report FDA Received Date09/24/2020
Supplement Report FDA Received Date11/05/2020
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
ACTIS COLLARED HIGH SIZE 6; ARTICUL/EZE BALL 28 +1.5 GR; ACTIS COLLARED HIGH SIZE 6; ARTICUL/EZE BALL 28 +1.5 GR
Outcome Attributed to Adverse Event Required Intervention;
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