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

Catalog Number 5531G709

Device Problems 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.

• Brand Name: X3 TRIATHLON CS INSERT #7 9MM
• Type of Device: PROSTHESIS, 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 Key: 5829965
• MDR Text Key: 51458789
• Report Number: 0002249697-2016-02457
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• 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 Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 5531G709
• Device Lot Number: LEY310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 113