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

Catalog Number 5530-G-311

Device Problem Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was retained by the patient and 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.

Event Description

The physician revised a triathlon cr beaded femur and a primary tibia baseplate for universal due to instability.Left knee.Update as per maude report #mw5058475, doa (b)(6) 2016: voluntary (b)(6) 2015 12:59:07.00: i had a total left knee replacement with a stryker triathlon implant in (b)(6) 2009.I continued to have knee pain as well as pain down my leg.I was told to continue physical therapy.After 3 years the implant started to fail.I continued to have knee pain in the back/inside of my knee for 3 more years.After 6 years, i ended up having a total knee revision in (b)(6) 2015 because the implant failed.They replaced it with the stryker triathlon again with a stem in my femur and added a stabilizer.I wore through the tibial insert and triathlon baseplate and had metal shavings floating around my knee.

Manufacturer Narrative

An event regarding wear involving a triathlon cr x3 tibial insert was reported.The event was not confirmed.Method & results: - 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 medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

The physician revised a triathlon cr beaded femur and a primary tibia baseplate for universal due to instability.Left knee.Update as per maude report #mw5058475, doa 1/4/2016: voluntary 14-dec-2015 12:59:07.00: i had a total left knee replacement with a stryker triathlon implant in (b)(6) 2009.I continued to have knee pain as well as pain down my leg.I was told to continue physical therapy.After 3 years the implant started to fail.I continued to have knee pain in the back/inside of my knee for 3 more years.After 6 years, i ended up having a total knee revision in (b)(6) 2015 because the implant failed.They replaced it with the stryker triathlon again with a stem in my femur and added a stabilizer.I wore through the tibial insert and triathlon baseplate and had metal shavings floating around my knee.

• Brand Name: TRIATHLON CR 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5397534
• MDR Text Key: 37058264
• Report Number: 0002249697-2016-00211
• 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: consumer,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/08/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Catalogue Number: 5530-G-311
• Device Lot Number: MERNM0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 01/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2008
• 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 Age: 53 YR
• Patient Weight: 92