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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 9MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 9MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5531G709
Device Problems Lock (870); Ring (943); Difficult to Insert (1316); Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Patient Problems Tissue Damage (2104); No Consequences Or Impact To Patient (2199)
Event Date 06/30/2016
Event Type  Malfunction  
Manufacturer Narrative

Additional information has been requested. Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

 
Event Description

During procedure it was noted that the 7 x 9 cs insert locking ring did not appear to be normal. Decided not to use. Procedure was a primary right total knee. There was a surgical delay of approximately 3 minutes. No other adverse consequences to the patient.

 
Manufacturer Narrative

An event regarding a seating/locking issue involving a triathlon insert was reported. The event was confirmed. Method & results: -device evaluation and results: the observed damage on the posterior aspect of the insert would be indicative of an obstruction during attempted seating of the insert onto the baseplate. The observed damage on the locking wire would be indicative of attempted assembly of the insert onto the baseplate. -medical records received and evaluation: not performed as no medical records were provided. -device history review: dhr review for the reported lot was satisfactory. -complaint history review: chr review for the reported lot confirmed that there are no other similar events reported. Conclusions: based on the visual inspection of the returned component, the observed damage on the posterior aspect of the insert would be indicative of an obstruction during attempted seating of the insert onto the baseplate. The observed damage on the locking wire would be indicative of attempted assembly of the insert onto the baseplate. A capa trend analysis was conducted for the reported failure mode and concluded that seating/locking difficulties may arise from user-related issues associated with the preparation of the joint space prior to the attempted seating and with the technique required to correctly introduce the insert component to the baseplate. No further investigation for this event is required at this time.

 
Event Description

During procedure it was noted that the 7 x 9 cs insert locking ring did not appear to be normal. Decided not to use. Procedure was a primary right total knee. There was a surgical delay of approximately 3 minutes. No other adverse consequences to the patient.

 
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Brand NameX3 TRIATHLON CS INSERT #7 9MM
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 colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5829965
MDR Text Key51458789
Report Number0002249697-2016-02457
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 HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/30/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/28/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5531G709
Device LOT NumberLEY310
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/02/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/11/2016
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: 07/28/2016 Patient Sequence Number: 1
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