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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX58OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX58OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Catalog Number 121887458
Device Problem Difficult to Remove (1528)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); No Code Available (3191)
Event Date 01/16/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Initial reporter occupation: lawyer. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

After the review of medical records, it was stated that the patient was revised to address pain. Additionally, elevated metal ion levels, pseudocyst tumors, and metallosis were noted. There were two operations occurring that day since the earlier revision was unsuccessful due to difficulty in removing the liner from the shell; there was no explant system available at that time. The second operation was successfully done on the same day after additional instrumentation was secured. Revision notes reported trunnionosis, mild synovial staining, and hypertrophy of synovium. It was also reported that the surgeon replaced the newly implanted +4, 10 degree lipped liner to a 10-degree neutral liner since it was causing a cam impingement and dislocation intraoperatively. Doi: (b)(6) 2008; dor: (b)(6) 2019; right hip.

 
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Brand NamePINNACLE MTL INS NEUT40IDX58OD
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 8DT
UK LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9813674
MDR Text Key188469425
Report Number1818910-2020-07383
Device Sequence Number1
Product Code KWA
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062426
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 02/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2013
Device Catalogue Number121887458
Device LOT Number2513939
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 Received04/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/17/2008
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: 03/10/2020 Patient Sequence Number: 1
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