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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX56OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX56OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Model Number 1218-87-456
Device Problem Naturally Worn (2988)
Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Osteolysis (2377); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/10/2020
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

Pcf and medical records received. After review of medical records patient was revised to addressed pain, metallosis debris in the joint, elevated metal ions levels, scar in pseudocapsule, some lysis in the area of the trochanter and area of anterior-superior wall of the cup. Cup was removed with minimal bone loss and was in retroverted position. Doi: (b)(6) 2008 dor: (b)(6) 2020 right hip. Please see (b)(4) for left hip.

 
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Brand NamePINNACLE MTL INS NEUT40IDX56OD
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 Key11021515
MDR Text Key222004802
Report Number1818910-2020-27107
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 OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/16/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2013
Device MODEL Number1218-87-456
Device Catalogue Number121887456
Device LOT Number2665175
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 Received01/21/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/26/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 12/16/2020 Patient Sequence Number: 1
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