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

Catalog Number 5530-G-411

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

Patient Problems Calcium Deposits/Calcification (1758); Pain (1994); Injury (2348)

Event Date 06/02/2017

Event Type  Injury  

Manufacturer Narrative

Catalog numbers and lot codes of other devices listed in this report: cat #5554l320, lot #sf8ds, description: triathalon mb patella pa a32.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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 device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.

Event Description

It was reported that patient's right knee was revised; patient complained of anterior knee pain.

Manufacturer Narrative

An event regarding pain involving a triathlon insert was reported.The event was not confirmed.Device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: based upon x-ray information, the cause for this appears to be the abnormal calcifications around the patellar device.This is not related to mal-performance of an implanted arthroplasty device but related to abnormal bone formation along the patellar bone, outside the patellar component along the lateral and superior border of the component.Such problems are far from rare and comparable to heterotopic bone formation after hip arthroplasty.A similar problem is seen in the patient¿s opposite knee were a patellofemoral prosthesis is implanted and also with abnormal bone formation around the patellar device.This is a patient-related problem due to degenerative disease progress as probably related to contact of the patellar bone border to the metal of the femoral component in the trochlear groove.Such bony changes may at times continue even after adequate surface replacement of the patella.-device history review: 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.Based upon x-ray information, the cause for this appears to be the abnormal calcifications around the patellar device.The medical review noted abnormal calcifications in the pf-joint after knee arthroplasty have contributed to interference with optimal functionality of the pf-joint device causing anterior knee pain requiring revision.This is not related to mal-performance of an implanted arthroplasty device but related to abnormal bone formation along the patellar bone, outside the patellar component along the lateral and superior border of the component.Such problems are far from rare and comparable to heterotopic bone formation after hip arthroplasty.This is a patient-related problem due to degenerative disease progress as probably related to contact of the patellar bone border to the metal of the femoral component in the trochlear groove.The reported insert was most likely removed to provide additional space in the knee to address the patella issue more easily however further information such as revision operative notes are need to determine a definitive root cause.Pain can occur post-operatively for a number of reasons and is a symptom rather than the cause of the issue the patient is experiencing.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this investigation will be reopened.

Event Description

It was reported that patient's right knee was revised; patient complained of anterior knee pain.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6672100
• MDR Text Key: 78542134
• Report Number: 0002249697-2017-02040
• 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: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2013
• Device Catalogue Number: 5530-G-411
• Device Lot Number: 9W5MNE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2008
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 87