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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 56MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 56MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-32-056
Device Problems Osseointegration Problem (3003); Migration (4003)
Patient Problems Ossification (1428); Adhesion(s) (1695); Cyst(s) (1800); Foreign Body Reaction (1868); Unspecified Infection (1930); Scar Tissue (2060); Discomfort (2330); Inadequate Osseointegration (2646); Muscle/Tendon Damage (4532); Unspecified Musculoskeletal problem (4535); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/13/2011
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Litigation alleges loosening. Update ad 16 nov 2021 ppf, pfs and medical records received. Ppf has no new allegation. In addition to what previously alleged, pfs alleges stiffness and discomfort. After review of medical records patient was revised was due to loose acetabular component. Operative notes indicated that there were osteophytes present superiorly and anteriorly as well as soft tissue had to be debrided. The broken screw could be seen at that point. It appeared that the flange on the screw head had broken off or worn away and the screw had bent with almost 90 degrees angle posteriorly as the cup traveled posteriorly. The overall quality of the acetabulum was good. There were cystic areas but there were also very sclerotic areas an unusual undulating areas of sclerotic bone presumably due to metal impingement and reaction to wear. There were adhesion present, tendonitis, some slightly grayish fluid and the screw was sitting proud. Doi: (b)(6) 2008 - dor: (b)(6) 2011 (right hip) first revision.
 
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Brand NamePINN SECTOR W/GRIPTION 56MM
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 Key12850892
MDR Text Key281193148
Report Number1818910-2021-25885
Device Sequence Number1
Product Code KWA
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,Followup
Report Date 05/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1217-32-056
Device Catalogue Number121732056
Device Lot NumberB3PFH1000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2007
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: 11/22/2021 Patient Sequence Number: 1
Treatment
12/14 ARTICUL 40MM M SPEC+5.; PINN CAN BONE SCREW 6.5MMX30MM.; PINN SECTOR W/GRIPTION 56MM.; PINNACLE MTL INS NEUT40IDX56OD.; SUMMIT POR TAPER SZ6 HI OFF.
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