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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 52MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 121722052
Device Problem Device-Device Incompatibility (2919)
Patient Problem Not Applicable (3189)
Event Date 08/14/2019
Event Type  Malfunction  
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 the cup (p/n: 121722052) and the impactor (manufactured by fuji flex, p/n: apjp0740) were not able to separate when the surgeon inserted the cup during the tha surgery of the patient¿s left hip joint on (b)(6) 2019. (the cup and the impactor had been remaining in inseparable after all) the surgery was completed by using another same size multi-hole type cup and a standard cup impactor. There was within a 30 minutes surgical delay and there was no adverse consequence to the patient. No further information is available.

 
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Brand NamePINNACLE SECTOR II 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 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key8960506
MDR Text Key156450188
Report Number1818910-2019-103057
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeJA
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,Followup,Followup,Followup
Report Date 08/14/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number121722052
Device LOT Number9159608
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/18/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/20/2019
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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