MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5532-G-609

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Loss of Range of Motion (2032)

Event Date 09/21/2016

Event Type  Injury  

Manufacturer Narrative

The following other devices were also listed in this report: tri ts femur sz5 left; cat# 5512-f-501; lot# veoi, tri post augment sz5 5mm; cat# 5543-a-500; lot# unknown, triathlon asymmetric x3 patella; cat# 5551-g-401; lot# unknown, tri press-fit stem 22mm x 100mm; cat# 5565-s-022; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

Revision of left knee.Patient complained of lack of motion.

Manufacturer Narrative

An event regarding lack of motion involving a triathlon insert was reported.The event was not confirmed.Method and results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.A capa trend analysis was conducted for the reported failure mode and concluded lack of motion may result from other factors not necessarily related to the device.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Revision of left knee.Patient complained of lack of motion.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6041905
• MDR Text Key: 57916161
• Report Number: 0002249697-2016-03280
• 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: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 5532-G-609
• Device Lot Number: MMK7DW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2013
• 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): Required Intervention
• Patient Weight: 143