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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 54MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 54MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-22-054
Device Problems Use of Device Problem (1670); Malposition of Device (2616)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); No Code Available (3191)
Event Date 07/16/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial reporter occupation: lawyer. (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
Unf and medical records received. After review of medical records, it was indicated that the patient had bilateral hip pain. The patient was then revised for left-sided hip pain and elevated metal ion levels concerning for metallosis. Operative notes reported that there was a small pseudotumor that had a very little amount of fluid. Bony overgrowth over the acetabular component was removed and the acetabular component was retroverted. Doi: (b)(6) 2005; dor: (b)(6) 2018; left hip. The patient has bilateral hip implants, please see (b)(4) for the right hip.
 
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Brand NamePINNACLE SECTOR II CUP 54MM
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 Key9786164
MDR Text Key181973295
Report Number1818910-2020-06779
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003523
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1217-22-054
Device Catalogue Number121722054
Device Lot NumberZ5VGJ1000
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 Received04/02/2020
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: 03/04/2020 Patient Sequence Number: 1
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