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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT Back to Search Results
Catalog Number UNK_REC
Device Problems Inadequacy of Device Shape and/or Size (1583); Unstable (1667)
Patient Problem No Code Available (3191)
Event Date 06/04/2015
Event Type  Injury  
Event Description

It was reported that the knee was unstable. Doctor replaced the 11 mm ps insert with 16 mm ts triathlon insert.

 
Manufacturer Narrative

Catalogue number unknown at this time. Device description reported as an unknown size 8 ps 11mm triathlon insert. An evaluation of the device cannot be performed as the device was retained by the hospital and was not returned to the manufacturer. Additional information has been requested, but not made available. Should additional information become available it will be reported in a supplemental report upon completion of the investigation. Not returned to the manufacturer.

 
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Brand NameUNKNOWN_RECONSTRUCTIVE_PRODUCT
Type of DeviceIMPLANT
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
jadwiga degrado
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4878884
MDR Text Key22067594
Report Number0002249697-2015-02139
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 06/04/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_REC
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/04/2015
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: 06/30/2015 Patient Sequence Number: 1
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