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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX54OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX54OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Model Number 1218-87-354
Device Problem Naturally Worn (2988)
Patient Problems Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/31/2020
Event Type  malfunction  
Manufacturer Narrative
Clinical symptoms code: appropriate term/code not available (e2402) used to capture blood heavy metal increased. 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. After review of medical records patient was revised to addressed pain, discomfort, injury, elevated cobalt and chromium levels, decreased range of motion. Clinic visits reported of leg length discrepancy, stiffness and wear debris. Patient is scheduled for left revision and underwent therapy. Doi: (b)(6) 2008, dor: scheduled left hip. (b)(4) right hip 1st revision, (b)(4) right hip 2nd revision.
 
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Brand NamePINNACLE MTL INS NEUT36IDX54OD
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 ORTHOPAEDICS 1818910
700 orthopaedic dr
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10991767
MDR Text Key220932890
Report Number1818910-2020-26796
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 other
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/30/2013
Device Model Number1218-87-354
Device Catalogue Number121887354
Device Lot Number2617149
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 Received01/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/14/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/11/2020 Patient Sequence Number: 1
Treatment
APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; PINNACLE 100 ACET CUP 54MM; PINNACLE MTL INS NEUT36IDX54OD; SUMMIT POR TAPER SZ6 STD OFF
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