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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #2 9MM IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #2 9MM IMPLANT Back to Search Results
Catalog Number 5531G209
Device Problems Material Discolored (1170); Pitted (1460); Delamination (2904); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Injury (2348)
Event Date 06/10/2015
Event Type  Injury  
Event Description

As per sales rep, patient was revised due to infection. The operating surgeon is concerned why poly at 6 years is delaminating, pitting and turning yellow.

 
Manufacturer Narrative

The following other devices were also listed in this report: triathlon cr fem comp #3 r-cem; cat# 5510-f-302; lot# sn6jb. Triathlon prim cem fxd bplt #2; cat# 5520-b-200; lot# unknown. It cannot be determined which, if any of these devices may have caused or contributed to the patient's infection. When completed, the investigation results will be submitted in a supplemental report.

 
Manufacturer Narrative

An event regarding infection involving a triathlon insert was reported. The event was not confirmed. Method & results: device evaluation and results: a material analysis has been performed. The report concluded: in-vivo service related damages to the returned triathlon cs insert included burnishing, delamination, scratching and third body indentations. All of these are commonly identified damage modes on uhmwpe. Yellow discoloration on the insert was likely due to absorption of synovial fluid. Damage was also present on the baseplate and femoral component. The damage on the insert, baseplate and femoral component was likely due to posterior articulation of the femoral component on the insert. No material or manufacturing defects were observed on the surfaces examined. Medical records received and evaluation: not performed as medical records were not provided. Device history review: indicated the device was manufactured and accepted into final stock with no reported discrepancies. Complaint history review: indicated that there have been no other similar reported events for the lot or sterile lot referenced. Conclusions: the exact root cause of the event could not be determined due to insufficient provision of information. Further information such as: pre- and post-operative x-rays; operative reports as well as patient history, follow up notes and pathology reports are needed to complete the investigation to determine root cause. It should also be noted that the operating surgeon was reportedly concerned why poly at 6 years is delaminating, pitting and turning yellow. This concern is addressed by the mar conclusion, above. A capa trend analysis was conducted for the reported failure mode and concluded infection is a known possible adverse outcome of surgery and is beyond stryker's control. No further investigation is possible at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

As per sales rep, patient was revised due to infection. The operating surgeon is concerned why poly at 6 years is delaminating, pitting and turning yellow.

 
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Brand NameX3 TRIATHLON CS INSERT #2 9MM
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK (MDR)
raheen business park
limerick 00000
EI 00000
Manufacturer Contact
william hanna
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4896041
MDR Text Key6835314
Report Number0002249697-2015-02224
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,HEALTH PROFESSIONAL,OTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/07/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2014
Device Catalogue Number5531G209
Device LOT NumberLBP405
OTHER Device ID NumberSTERILE LOT# K8XG7
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/25/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/12/2009
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: 07/07/2015 Patient Sequence Number: 1
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