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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 2 HI OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 2 HI OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 101214020
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Inflammation (1932); Itching Sensation (1943); Muscle Spasm(s) (1966); Pain (1994); Tissue Damage (2104); No Code Available (3191)
Event Date 02/08/2012
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Pinnacle ppf and medical records received. Pfs alleges dislocation and metallosis. After review of medical records for mdr reportability, the patient was revised to address metallosis, inflammation, and previous dislocation. Surgical notes also reported pruritus due to pain and muscle spasm. Blood work also determined that patient had high metal levels and reported that the cup was exchanged with findings of inflammation and moderate amount of dark tinged fluid with consistent metallosis and consistent pain. The patient also had an anemia of acute blood loss not necessitating transfusion. Doi: (b)(6) 2009; dor: (b)(6) 2012; left hip.
 
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Brand NameTRI-LOCK BPS SZ 2 HI OFFSET
Type of DeviceTRILOCK HIP STEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581-0988
5743725905
MDR Report Key7506508
MDR Text Key107986103
Report Number1818910-2018-59378
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 04/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/14/2019
Device Catalogue Number101214020
Device Lot NumberD1WED1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/16/2009
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: 05/11/2018 Patient Sequence Number: 1
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