MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #4 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5510F402

Device Problem Insufficient Information (3190)

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

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate 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.

Event Description

In reporting a revision of patient's right knee on (b)(6) 2018, rep provided an exam note and operative report which indicate the patient underwent arthroscopy with scar tissue removal on (b)(6) 2018 with the observation.No devices were explanted at that time.

Event Description

In reporting a revision of patient's right knee on 16/jul/2018, rep provided an exam note and operative report which indicate the patient underwent arthroscopy with scar tissue removal on 07/mar/2018 with the observation.No devices were explanted at that time.

Manufacturer Narrative

An event regarding arthrofibrosis involving a triathlon femoral component was reported.The event was confirmed.Method & results: -device evaluation and results: not performed as product was not returned -medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: review of these records confirms arthrofibrosis (excessive proliferation of scar tissue) following tka occurred.Arthrofibrosis is a multifaceted complication of tka and the root cause in his instance cannot be determined as insufficient information was available.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: a review by a clinician indicated: review of these records confirms arthrofibrosis (excessive proliferation of scar tissue) following tka occurred.Arthrofibrosis is a multifaceted complication of tka and the root cause in his instance cannot be determined as insufficient information was availablethe exact cause of the event could not be determined because insufficient information was provided and the device was not returned.Further information such as operative reports fro the arthroscopic surgery, dated pre and post op x-rays/ imaging from the index and revision surgeries, outpatient office/clinic notes as well as physical therapy notes are needed to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON CR FEM COMP #4 R-CEM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7779568
• MDR Text Key: 116996735
• Report Number: 0002249697-2018-02511
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327040289
• UDI-Public: 07613327040289
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 5510F402
• Device Lot Number: BYS2D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 86