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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE SECTOR II CUP 54MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE SECTOR II CUP 54MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 121722054
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); No Code Available (3191)
Event Date 01/01/2013
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Device was used for treatment, not diagnosis. Initial reporter occupation: non-healthcare professional "attorney". (b)(4).
 
Event Description
Litigation alleges the patient suffers from pain, dislocation and metal on metal issues. Update the patient was revised for instability and metallosis. No revision operative note was provided. Update in addition to what previously alleged, ppf alleges dislocation, infection and elevated metal ions before first revision. Doi: (b)(6) 2004 - dor: (b)(6) 2013 (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. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380
6107428552
MDR Report Key8381537
MDR Text Key137514371
Report Number1818910-2019-86127
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number121722054
Device Lot NumberX76EM1000
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 Received11/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/10/2003
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: 03/01/2019 Patient Sequence Number: 1
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