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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH MIS MODULAR DISTAL CAPTURE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 6541-5-723
Device Problems Disassembly (1168); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 10/20/2015
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that, during a tka, the reported device was disassembled. There was no health damage on this event. The device was shipped to the customer before product hold.

 
Manufacturer Narrative

An event regarding an alleged disassembly issue involving a modular distal capture was reported. The event was confirmed. Method & results: device evaluation and results: a visual analysis confirmed the device was returned in used condition. The pin, spring, locking knob and body were separated. Dimensional inspection indicated the pin was undersized. Medical records received and evaluation: not performed as no medical records were provided. Device history review: confirmed all devices accepted into finished goods conformed to specification. Complaint history review: no other events were reported for the lot indicated. Conclusions: the investigation concluded that the pin subcomponent was undersized and exhibited a lack of press-fit with the locking knob. Nc was initiated on (b)(6) 2015 for a lack of press-fit between the pin and locking knob subcomponents of triathlon mis modular distal captures. The root cause was determined to be that the supplier was manufacturing the pins in an undersized condition.

 
Event Description

It was reported that, during a tka, the reported device was disassembled. There was no health damage on this event. The device was shipped to the customer before product hold.

 
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Brand NameMIS MODULAR DISTAL 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 navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5229115
MDR Text Key31591884
Report Number0002249697-2015-03774
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/20/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/17/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6541-5-723
Device LOT NumberAF3L05
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/02/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/18/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number2249697-10/6/2015-011R

Patient TREATMENT DATA
Date Received: 11/17/2015 Patient Sequence Number: 1
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