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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX54OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX54OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Model Number 1218-87-354
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Swelling/ Edema (4577)
Event Date 10/24/2012
Event Type  Injury  
Event Description
Medical record received. After review of medical record, patient was revised to address painful left total hip, mom reaction. Revision notes stated that there was obvious distention of posterior rotators or capsule that was aspirated and found to be milky colored. There was obvious metal staining of the synovium. There was corrosion on the taper. Medical records indicate that the corrosion on the trunnion of the femoral stem was cleaned off. The stem and sleeve were well-fixed and therefore retained. Doi: (b)(6) 2007 - dor: (b)(6) 2012 (left hip).
 
Manufacturer Narrative
Product complaint # (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.
 
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Brand NamePINNACLE MTL INS NEUT36IDX54OD
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13770508
MDR Text Key287193652
Report Number1818910-2022-04730
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 03/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2011
Device Model Number1218-87-354
Device Catalogue Number121887354
Device Lot Number2255752
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/24/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/15/2022 Patient Sequence Number: 1
Treatment
PINN CAN BONE SCREW 6.5MMX20MM; PINNACLE SECTOR II CUP 54MM; S-ROM M HEAD 36MM +6; S-ROM*SLEEVE PRX ZTT, 20B-LRG; SROM*STM ST,36+8L NK,20X15X165
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