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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 56MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 56MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-01-056
Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Patient Problem No Code Available (3191)
Event Date 06/27/2020
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

It was reported that according to the surgeon, patient experienced pinnacle liner dissociation, as evidenced on x-ray. This finding was confirmed intra-op. Multiple ard tabs were broken off of the liner. The surgeon elected to keep the pinnacle shell, replacing the liner and femoral head. Doi: (b)(6) 2003; dor: (b)(6) 2020; right side.

 
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Brand NamePINNACLE 100 ACET CUP 56MM
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 Key10252004
MDR Text Key198154222
Report Number1818910-2020-15412
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP070026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/09/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1217-01-056
Device Catalogue Number121701056
Device LOT NumberXA8G21015
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/08/2003
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: 07/09/2020 Patient Sequence Number: 1
Treatment
APEX HOLE ELIMINATOR; ARTICUL/EZE BALL 28 +5 BR; PINN MAR NEUT 28IDX56OD; SUMMIT POR TAPER SZ4 STD OFF
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