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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ6 STD OFF SUMMIT HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ6 STD OFF SUMMIT HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1570-01-120
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Discomfort (2330); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/26/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4). 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, metallosis, a 2 cm x 2 cm cystic lesion filled with gray material on the superior acetabulum and around the stem posterior aspect. Clinic visits reported of bursitis, squeaking, leg length discrepancy and wear debris. Doi: (b)(6) 2008, dor: (b)(6) 2019, right hip 1st revision.
 
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Brand NameSUMMIT POR TAPER SZ6 STD OFF
Type of DeviceSUMMIT HIP STEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10991728
MDR Text Key220927013
Report Number1818910-2020-26794
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup,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? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1570-01-120
Device Catalogue Number157001120
Device Lot NumberC2VH51000
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 Manufactured08/13/2008
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: 12/11/2020 Patient Sequence Number: 1
Treatment
APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +8.5; PINNACLE 100 ACET CUP 54MM; PINNACLE MTL INS NEUT36IDX54OD; SUMMIT POR TAPER SZ6 STD OFF
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