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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Model Number 1218-87-352
Device Problems Use of Device Problem (1670); Malposition of Device (2616)
Patient Problems Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)
Event Date 09/19/2014
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
After review of medical records, it was indicated that the patient complaints of significant thigh pain. Progressive radigraphs shows subsidence of the femoral stem. The patient was revised for failed total hip replacement, loose femoral stem, and adverse metal-on-metal reaction. Intraoperative findings stated that there was metalosis around the hip joint, but no significant loss of the abductor musculature or short external rotation musculature. The metal liner in the acetabulum was malpositioned and was situated in position which is asymmetric in the socket. The femoral stem was grossly loose. Doi: (b)(6) 2007; dor: (b)(6) 2014; left hip.
 
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Brand NamePINNACLE MTL INS NEUT36IDX52OD
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 anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9794675
MDR Text Key182291225
Report Number1818910-2020-07016
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003523
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 02/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2012
Device Model Number1218-87-352
Device Catalogue Number121887352
Device Lot Number2469373
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 Received04/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/25/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/05/2020 Patient Sequence Number: 1
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