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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 52X28 BLU; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
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DEPUY ORTHOPAEDICS INC US SELF CENT HIP 52X28 BLU; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Model Number 1035-52-000
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 06/28/2021
Event Type  Injury  
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 Description
It was reported as "dislocating bipolar head".Doi: unknown; dor: (b)(6) 2021; affected side: unknown hip.
 
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 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 device history record (mre) review, was not possible because the required lot code was not provided.
 
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Brand Name
SELF CENT HIP 52X28 BLU
Type of Device
HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12195793
MDR Text Key262415281
Report Number1818910-2021-15495
Device Sequence Number1
Product Code KWY
UDI-Device Identifier10603295003427
UDI-Public10603295003427
Combination Product (y/n)N
PMA/PMN Number
K812672
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1035-52-000
Device Catalogue Number103552000
Was Device Available for Evaluation? No
Date Manufacturer Received08/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARTICUL/EZE BALL 28 +1.5 GR.
Patient Outcome(s) Required Intervention;
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