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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MIS 4:1 MODULAR CAPTURE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH MIS 4:1 MODULAR CAPTURE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 6541-5-806
Device Problems Lock (870); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/17/2016
Event Type  Malfunction  
Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

 
Event Description

During triathlon surgery, the lock of the modular captures came off when the surgeon cutting the bone with them.

 
Manufacturer Narrative

An event regarding an assembly issue involving a triathlon guide was reported. The event was not confirmed. The two modular captures were returned and observed to be worn with signs of significant cyclic use. The distal surface of both captures showed abrasion damage due to contact with the saw blade. The captures were assembled to the guide from finished goods and confirmed to be fully functional. Not performed as there is no evidence to support the event was related to patient factors. Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies. There has been no other event for the lot referenced. The investigation concluded the returned devices to be fully functional. However, the devices were observed to be worn with signs of significant cyclic use. It is likely the locking spring could not stay locked in the middle of vibration due to normal wear. If additional information becomes available, this investigation will be reopened.

 
Event Description

During triathlon surgery, the lock of the modular captures came off when the surgeon cutting the bone with them.

 
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Brand NameMIS 4:1 MODULAR CAPTURE
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5790981
MDR Text Key50087627
Report Number0002249697-2016-02316
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
PMA/PMN NumberK123486
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 06/17/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/13/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6541-5-806
Device LOT NumberSB5M18
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/24/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/23/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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