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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Loss of Range of Motion (2032)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter occupation: lawyer. Adverse event review: the report that the patient has now been identified as deceased has been reviewed in the context of the medical records and pfs allegations provided. It was indicated that the patient was deceased, but none of the allegations provided allege or suggest that the patient's death was in any way related to the depuy products or associated procedures. Additionally, the patient's revision surgery occurred in 2013, but per her employment record, it was noted that she did not leave her employment with avon until 2019, due to her death, six years later. It is reasonable to conclude that based upon the information currently available that there is no evidence or allegation that the death of this patient is related to depuy devices or procedures. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Pfs and medical records received. Pfs reported that patient post 1st revision patient still complaints of pain, aches, limitations with activity, high cobalt and chromium levels continued until death. After review of medical records, it was reported that patent suffered post operative acute blood loss anemia. Doi: (b)(6) 2005 (stem,sleeve), doi: (b)(6) 2013 (cup,screws,apex,liner,head), dor: none reported, (left hip).
 
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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, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12333831
MDR Text Key266979371
Report Number1818910-2021-18035
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 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1217-32-056
Device Catalogue Number121732056
Device Lot Number400791
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/11/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/17/2021 Patient Sequence Number: 1
Treatment
ALTRX +4 NEUT 36IDX56OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 11/13 36MM +3; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN SECTOR W/GRIPTION 56MM; S-ROM*SLEEVE PRX ZT, 18F-XXL; SROM*STM ST,30+4L NK,18X13X160
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