MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #6 CR INSERT 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530P611

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

Patient Problems Loss of Range of Motion (2032); Scar Tissue (2060); Injury (2348)

Event Date 08/01/2008

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: triathlon cr fem comp #6 l-cem; cat# 5510f601; lot# l5eot; triathlon prim tib baseplate - cemented; cat# 5520-b-600; lot# uiid; duracon duration conv patel md; cat# 6642-2-705; lot# tcpd305a; it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicates the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.

Event Description

The patient had arthroscopic surgery in (b)(6) 2008 (approximate date) to remove excessive tissue following knee surgery in 2006.

Manufacturer Narrative

An event regarding arthrofibrosis involving a triathlon insert was reported.The event was confirmed through medical records.Device evaluation and results: not performed as no items were returned.Medical records received and evaluation: total knee arthroplasty requiring extensile exposure with additional patient-related risk factors of poor knee function with severe varus deformity prior to arthroplasty has resulted in arthrofibrosis with impairment of knee functionality.An arthroscopic release of scar tissue has been performed some time post arthroplasty although knee functionality did not improve significantly.Patient remained dissatisfied with the outcome of arthroplasty with limited knee flexion and an extension deficit although complaints were not severe enough to indicate revision surgery.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: the medical review indicated that total knee arthroplasty requiring extensile exposure with additional patient-related risk factors of poor knee function with severe varus deformity prior to arthroplasty has resulted in arthrofibrosis with impairment of knee functionality.An arthroscopic release of scar tissue has been performed some time post arthroplasty although knee functionality did not improve significantly.Patient remained dissatisfied with the outcome of arthroplasty with limited knee flexion and an extension deficit although complaints were not severe enough to indicate revision surgery.A capa trend analysis was conducted for the reported failure mode and concluded that 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

The patient had arthroscopic surgery in (b)(6) 2008 (approximate date) to remove excessive tissue following knee surgery in 2006.

• Brand Name: TRIATHLON #6 CR INSERT 11MM
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6904944
• MDR Text Key: 87791115
• Report Number: 0002249697-2017-02892
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2010
• Device Catalogue Number: 5530P611
• Device Lot Number: LU509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2005
• 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: 60 YR
• Patient Weight: 78