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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 41X28 RUST; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
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DEPUY ORTHOPAEDICS INC US SELF CENT HIP 41X28 RUST; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Model Number 1035-41-000
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 01/21/2021
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
It was reported that this is the 2nd revision for the patient.Same issue.Size 41 bipolar locking ring broke from impingement.The patient has a fused knee on the same leg.Doi: (b)(6) 2020, dor: (b)(6) 2021, affected side: right 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: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
 
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Brand Name
SELF CENT HIP 41X28 RUST
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 Key11266678
Report Number1818910-2021-02274
Device Sequence Number3374339
Product Code KWY
UDI-Device Identifier10603295003311
UDI-Public10603295003311
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
K812672
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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) 01/21/2021
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 Number1035-41-000
Device Catalogue Number103541000
Device Lot NumberH60045
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/21/2021
Supplement Date Received by Manufacturer03/03/2021
Initial Report FDA Received Date02/02/2021
Supplement Report FDA Received Date03/04/2021
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
ARTICUL/EZE BALL 28 +1.5 GR; SELF CENT HIP 41X28 RUST; ARTICUL/EZE BALL 28 +1.5 GR; SELF CENT HIP 41X28 RUST
Outcome Attributed to Adverse Event Required Intervention;
Patient Age74 YR
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