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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 52MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 52MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 121701052
Device Problem Device-Device Incompatibility (2919)
Patient Problem Not Applicable (3189)
Event Date 08/30/2019
Event Type  Malfunction  
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

Intraoperatively the cup impactor was not possible to disconnect from the hip-cup. Another instrument / implant was available and inserted without issue. No patient harm, surgical delay < 5 minutes.

 
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Brand NamePINNACLE 100 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 drive
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9098269
MDR Text Key159519246
Report Number1818910-2019-105601
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK000306
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/02/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/20/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number121701052
Device LOT Number9227098
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/25/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/29/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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