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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX60OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX60OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Model Number 1218-87-460
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/19/2019
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
Pinnacle medical records received. After review of medical records, patient was revised to address metallosis and loose femoral stem. During clinical visits, patient has mild leg length discrepancy, scar and pain on exam and radiographs revealed eccentrically placed metal liner. Revision notes stated that there was minimal scar, small amount of joint fluid was encountered. Fibrous tissue was removed at the cup and liner. It was mentioned that the metal ions were elevated however result shows below 7ppb. Doi: (b)(6) 2007; dor: (b)(6) 2019; (right hip).
 
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Brand NamePINNACLE MTL INS NEUT40IDX60OD
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 Key11601984
MDR Text Key243520408
Report Number1818910-2021-06752
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062426
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/30/2012
Device Model Number1218-87-460
Device Catalogue Number121887460
Device Lot Number2374113
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 Received04/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/11/2007
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: 04/01/2021 Patient Sequence Number: 1
Treatment
12/14 ARTICUL 40MM M SPEC+8.5; PINNACLE MTL INS NEUT40IDX60OD; PINNACLE SECTOR II CUP 60MM; PRODIGY LG STAT LNG RT 13.5MM
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