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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #3 R-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #3 R-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5510F302
Device Problems Product Quality Problem (1506); Device Packaging Compromised (2916); Compatibility Problem (2960); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2015
Event Type  Malfunction  
Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

 
Event Description

It was reported that upon opening a box labeled triathlon cruciate retaining femoral [right cemented], it was discovered that the inner content did not match the outer label.

 
Manufacturer Narrative

An event regarding a femoral component-labelled pack containing a baseplate involving a triathlon femoral component was reported. The event was confirmed. Method & results: -device evaluation and results: the unit carton was returned opened and damaged with no shrinkwrap present. The unit carton contains four product labels detaling a triathlon cruciate retaining femoral, catalogue number 5510-f-302 and lot code aht7l. No outer blister pack was returned. The inner blister pack returned unopened and contained a triathlon primary tibial baseplate, catalogue number 5520-b-300 and lot code amm6k. -medical records received and evaluation: not performed as no medical records were provided. -device history review: the device was manufactured and accepted into final stock on 25-june-2015 with no reported discrepancies. -complaint history review: there have been no other reported events for the lot referenced. Conclusions: the investigation concluded that at no point were the femoral component and baseplate co-exisiting at the (b)(4) manufacturing facility. The femoral components were fully distributed from the finished goods warehouse in (b)(4) manufacturing facility by 06-aug-2015. Manufacturing of the baseplates in the (b)(4) manufacturing facility commenced on 08-sep-2015. It is possible that the mix-up may have occurred in (b)(6) and stryker (b)(4) has raised a non-conformance, to address this issue in their facility. No further investigation for this event is required at this time.

 
Event Description

It was reported that upon opening a box labeled triathlon cruciate retaining femoral [right cemented] , it was discovered that the inner content did not match the outer label.

 
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Brand NameTRIATHLON CR FEM COMP #3 R-CEM
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-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5251327
MDR Text Key32198865
Report Number0002249697-2015-04080
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/05/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/25/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2020
Device Catalogue Number5510F302
Device LOT NumberAHT7L
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/13/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/15/2015
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: 11/25/2015 Patient Sequence Number: 1
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