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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 52MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 52MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-32-052
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Unspecified Tissue Injury (4559)
Event Date 01/19/2021
Event Type  Injury  
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
Revision of a depuy synthes acetabular cup, liner, and head. Implants removed were 52 pinnacle gription cup and a 32x52 neutral marathon liner. The 32 ceramic head was also removed as a 28 head was needed for the bi-mentum components. Primary surgery was done 5 years ago and the patient started to experience pain in 2019. The reason for revision was due to pain not loosening or implant failure. The surgeon said that the cup was oversized which was causing soft tissue irritation and pain for the patient. Cup and liner were well fixed. Stem was stable so was not revised.
 
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Brand NamePINN SECTOR W/GRIPTION 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 dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11252593
MDR Text Key229421597
Report Number1818910-2021-02112
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K093646
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1217-32-052
Device Catalogue Number121732052
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 Received04/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/29/2021 Patient Sequence Number: 1
Treatment
32 CERAMIC HEAD; PINN MAR NEUT 32IDX52OD; PINN SECTOR W/GRIPTION 52MM; UNKNOWN HIP FEMORAL STEM
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