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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
Model Number 1217-22-052
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Not Applicable (3189); No Code Available (3191)
Event Date 07/10/2020
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
Liner breakage& cup deformed. It was reported that during the surgery of total hip replacement operation, after insert the liner in place, knocked it, the liner was broken off, could not only removed the liner, removed the both liner and cup. Changed one size bigger implants to complete the surgery. The surgeon suspect may the cup was deformed or liner with some issue. The surgery delayed about half hour. The bone appearance was damaged, lost about 30ml blood. The patient is stable and in hospital now.
 
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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 dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10322332
MDR Text Key200387205
Report Number1818910-2020-16850
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K073504
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 07/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1217-22-052
Device Catalogue Number121722052
Device Lot Number9329177
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/11/2019
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: 07/24/2020 Patient Sequence Number: 1
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