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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 50MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 50MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-22-050
Device Problem Malposition of Device
Event Date 05/11/2020
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 they took out pinnacle cup, 2 bone screws, pinnacle metal insert,-2 femoral head. Replaced with zimmer cup, liner and depuy femoral head. Original implant date unknown. Doi: unknown. Dor: (b)(6) 2020. Affected side: left hip.

 
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Brand NamePINNACLE SECTOR II CUP 50MM
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 Key10093720
Report Number1818910-2020-12673
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/11/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1217-22-050
Device Catalogue Number121722050
Device LOT NumberC5TEW1000
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 Received07/08/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/07/2008
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: 05/27/2020 Patient Sequence Number: 1
Treatment
ARTICULEZE M HEAD 36MM -2
PINN CAN BONE SCREW 6.5MMX20MM
PINN CAN BONE SCREW 6.5MMX25MM
PINNACLE MTL INS NEUT36IDX50OD
PINNACLE SECTOR II CUP 50MM
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