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-309

Device Problems Device Damaged by Another Device (2915); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Injury (2348); Joint Disorder (2373)

Event Date 03/14/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Review of the batch manufacturing records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There has been no other event for the lot referenced.

Event Description

Sales rep reported a left knee revision surgery for a poly swap.

Manufacturer Narrative

An event regarding instability involving a triathlon insert was reported.The event was confirmed through medical records.-device evaluation and results: no product was returned for evaluation.Two photographs of the explanted device were attached.The photographs show damage of the polyethylene in the postero-lateral corner of the bearing most likely caused by the femoral component riding over the posterior edge of the insert.There is also yellowing of the insert, this is consistent with in vivo use from absorption of synovial liquid protein.-medical records received and evaluation: x-rays confirm an adequate and stable cemented position of components where the femoral component is in posterior subluxation position and as such riding over the posterior edge of the tibial bearing, probably also contacting the metal of the baseplate.Adequate posterior tibial slope and posterior femoral condylar offset as stability parameters although the joint line is on the low side when compared to the tip of the fibula.The lateral joint space is thinner than the medial one.This knee is unstable.No further clinical information is available.-device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusions: images of the insert were provided, the images show damage of the polyethylene in the postero-lateral corner of the bearing.Clinician review of the records provided indicated that suboptimal thickness of the tibial bearing contributed to instability and allowed excessive rollback of the femur in flexion damaging the posterior edge of the tibial bearing.Polyethylene particle induced synovitis caused pain and swelling requiring revision.A capa trend analysis was conducted for the reported failure mode and concluded instability may result from other factors not necessarily related to the device.

Event Description

Sales rep reported a left knee revision surgery for a poly swap.

• 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-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6482719
• MDR Text Key: 72455894
• Report Number: 0002249697-2017-01205
• 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: 06/06/2017

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: 10/31/2012
• Device Catalogue Number: 5530-G-309
• Device Lot Number: 9WTMPD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2017
• Initial Date FDA Received: 04/11/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2007
• 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): Hospitalization; Required Intervention
• Patient Age: 88 YR