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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX56OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX56OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Model Number 1218-87-356
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Joint Laxity (4526); Physical Asymmetry (4573)
Event Date 01/27/2005
Event Type  Injury  
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.
 
Event Description
Pinnacle mom medical records received. After review of the medical records the patient was revised to address instability, subluxation, clunking of the hip. Operative note reported the hip was subluxing anteriorly. There was some excessive longitudinal instability of the hip, serous drainage was encountered in the hip joint and some excessive anteversion. Shortening was performed resulted to some anterior instability. Doi: (b)(6) 2005;dor: (b)(6) 2005; left hip.
 
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Brand NamePINNACLE MTL INS NEUT36IDX56OD
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 Key13769746
MDR Text Key287186824
Report Number1818910-2022-04685
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 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 Model Number1218-87-356
Device Catalogue Number121887356
Device Lot Number1209094
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/18/2004
Is the Device Single Use? Yes
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/15/2022 Patient Sequence Number: 1
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