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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/-5 HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE

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STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/-5 HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE Back to Search Results
Catalog Number 6260-9-036
Device Problems Material Erosion (1214); Insufficient Information (3190)
Patient Problems Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414); Reaction to Medicinal Component of Device (4574)
Event Date 10/18/2019
Event Type  Injury  
Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation. Not returned.

 
Event Description

A patient's hip was revised due to pain, elevated chromium levels, and trunnion residue. A 36 mm head and liner were revised to a ceramic head with sleeve, and a new liner.

 
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Brand NameV40 COCR LFIT HEAD 36MM/-5
Type of DeviceHIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
alessandra chavez
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key9328877
MDR Text Key166743506
Report Number0002249697-2019-03776
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK173499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/25/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/15/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2020
Device Catalogue Number6260-9-036
Device LOT Number3N70TK
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 11/15/2019 Patient Sequence Number: 1
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