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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 62MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 62MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-32-062
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Fluid Discharge (2686); Unspecified Tissue Injury (4559)
Event Date 02/09/2021
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
Medical records received. After review of medical records, it was reported that the patient had a draining of surgical wound procedure with extensive soft tissue necrosis secondary to metallosis from previous explanted metal on metal tha. Operative note reported that, upon entering the wound there was noted to be extensive soft tissue necrosis with a incomplete fascia layer. Some of the necrosis extended into the subcutaneous tissues. The proximal vastus lateralis was identified, this too appeared necrotic. Doi: (b)(6) 2007 (cup, screw, stem), doi: (b)(6) 2021 (head, liner), doe: (b)(6) 2021, right hip.
 
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Brand NamePINN SECTOR W/GRIPTION 62MM
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 1818910
700 orthopaedic dr
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12089133
MDR Text Key259150165
Report Number1818910-2021-13845
Device Sequence Number1
Product Code KWA
UDI-Device Identifier10603295010357
UDI-Public10603295010357
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093646
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1217-32-062
Device Catalogue Number121732062
Device Lot NumberB5KDX1000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2007
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: 06/29/2021 Patient Sequence Number: 1
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