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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR HA ACET CUP 52MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS INC US PINN SECTOR HA ACET CUP 52MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-12-052
Device Problem Difficult to Remove (1528)
Patient Problems Not Applicable (3189); No Code Available (3191)
Event Date 01/01/2020
Event Type  Injury  
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 Description

Surgeon revising corail pinnacle for dislocation. Insitu was a ceramic liner which would not disassociate from the pinnacle sector cup.

 
Manufacturer Narrative

Product complaint # (b)(4).

 
Search Alerts/Recalls

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Brand NamePINN SECTOR HA ACET CUP 52MM
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9779341
MDR Text Key181758749
Report Number1818910-2020-06608
Device Sequence Number1
Product Code KWA
Combination Product (Y/N)N
PMA/PMN NumberK073504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Type of Report Initial,Followup,Followup
Report Date 02/11/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1217-12-052
Device Catalogue Number121712052
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/03/2020 Patient Sequence Number: 1
Treatment
APEX HOLE ELIM POSITIVE STOP; EA DELTA CER INSERT 36IDX52OD; PINN SECTOR HA ACET CUP 52MM
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