MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G513

Device Problem Insufficient Information (3190)

Patient Problems Scar Tissue (2060); Injury (2348)

Event Date 11/23/2016

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.Device not available.

Event Description

Removal of scar tissue.Tibial bearing swap.

Manufacturer Narrative

An event regarding arthrofibrosis involving a triathlon insert was reported.The event was confirmed through medical records.Method & results: -device evaluation and results: not performed as no items were returned.-medical records received and evaluation: scar tissue was removed during revision with resection of the popliteal tendon and exchange of the bearing for a slightly thicker one going from 13-mm thickness to 16-mm cs bearing.An adequate functional result was obtained post revision.Range of motion (rom) of the knee was not reported prior to revision although it was mentioned to be reduced.A knee flexion of 120° is usually considered adequate while flexion less than 90° usually causes significant limitations with daily activities.Arthrofibrosis is a frequent problem of knee arthroplasty.The knee is a superficially located joint that is fully surrounded by a complex soft tissue envelope composed of joint capsule, ligaments, tendons and muscles all located close under the skin.All these structures play an important role in the functionality of the knee and as the knee requires extensile surgical exposure for a prosthesis to be implanted, it does not surprise that scar formation in any of these soft tissue components may lead to impairment of the knee function.-device history review: indicated devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: review of the medical records provided indicated that total knee arthroplasty requiring extensile exposure has resulted in arthrofibrosis with impairment of knee functionality together with popliteal tendon impingement.An extensive scar tissue release was performed with additional resection of the popliteal tendon in combination with liner exchange as required for adequate exposure and to restore adequate stability of the arthroplasty after the procedure.A capa trend analysis was conducted for the reported failure mode and concluded arthrofibrosis may result from other factors not necessarily related to the device.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Removal of scar tissue.Tibial bearing swap.

• Brand Name: X3 TRIATHLON CS INSERT #5 13MM
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6196578
• MDR Text Key: 63056931
• Report Number: 0002249697-2016-03978
• 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: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 5531G513
• Device Lot Number: LEB955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2014
• 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: 67 YR
• Patient Weight: 49