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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 64MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 64MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-32-064
Device Problem Migration (4003)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Physical Asymmetry (4573); Swelling/ Edema (4577)
Event Date 04/27/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Occupation: 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
Complaint description: patient was revised due to dislocation, and head disassociating from stem. On (b)(6) 2021: patient had been reported some clicking in the hip prior to the revision. Left hip is shortened and painful on range of motion and palpation and have some swelling. X-ray showed that the prosthesis had broken. Revision notes stated that the acetabular cup had shifted with anterior displacement of the stem. Cup, head, liner, and stem were removed.
 
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Brand NamePINN SECTOR W/GRIPTION 64MM
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 Key11844633
MDR Text Key251352490
Report Number1818910-2021-10611
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 consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1217-32-064
Device Catalogue Number121732064
Device Lot Number528882
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 Received07/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/29/2014
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: 05/18/2021 Patient Sequence Number: 1
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