MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON SYMMETRIC X3 PATELLA; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5550-G-278

Device Problems Malposition of Device (2616); Insufficient Information (3190)

Patient Problems Pain (1994); Burning Sensation (2146); Injury (2348)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

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

Patient called and stated that on (b)(6) 2013 she had a left tka.On or about (b)(6) 2014 she started experiencing pain running up and down her leg, as well as a burning sensation.Patient had a left tka revision on (b)(6) 2016.

Manufacturer Narrative

Additional information: brand name: product long description; product code, common device name; catalog#, lot#, expiration date; pma/510(k)#; manufacturing date.An event regarding malposition involving a triathlon patella was reported.The event was confirmed by medical review.Method & results: product evaluation and results: not performed as no products were returned.Clinician review: a review of the medical records by the consulting clinician indicated " throughout her post operative course she experienced patellofemoral related pain.In contrast the bony patella resection was significantly assymetric and the patella although midline showed significant lateral tilt.Review of serial xrays demonstrate progression of the patella tilt.On (b)(6) 2016 the patient was returned to the operating room for an arthroscopic procedure.An attempt was made to improve patella alignment by surgically releasing the soft tissue structures on the lateral aspect of the patella, a lateral retinacular release.Post operatively the patient continued to have difficulties requiring bracing and a cane.The surgeon notes in his postoperative visit notes that there is wear and degeneration of the patella.On (b)(6) 2017 a ct scan of the patella was performed which showed acute on chronic changes mildly displaced patella fragmentation with subluxation of the patella.Surgeon notes prior to the ct noted small per- patella bone fragments so the acuity of the ¿fracture noted on ct can not be verified.The prosthetic patella remained well fixed.Bracing and activity modification were continued.No further record of evaluation or treatment were provided.The primary harm involved is maltracking tka patella and possible periprosthetic tka patella fracture.The origin of this harm is most likely related to the asymmetric bony resection of the native patella causing patella tilt and asymmetric tracking.Attempts to alleviate this problem through alteration of the soft tissues via arthroscopic lateral release were unsuccessful.The acuity of ¿fracture¿ noted on ct scan report can not be verified.No ct images were available for review.Surgeon notes prior to the ct indicated small peri- patella bone fragments were present throughout her post-operative course.There is no evidence for defect in the implants or their manufacture." product history review: a review of the product history review indicated the devices accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event was confirmed for malposition.However, the root cause could not determined based on the conclusion of the medical review stated that "the origin of this harm is most likely related to the asymmetric bony resection of the native patella causing patella tilt and asymmetric tracking.Attempts to alleviate this problem through alteration of the soft tissues via arthroscopic lateral release were unsuccessful.The acuity of ¿fracture¿ noted on ct scan report can not be verified.No ct images were available for review.Surgeon notes prior to the ct indicated small peri- patella bone fragments were present throughout her post-operative course." if the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Patient called and stated that on (b)(6) 2013 she had a left tka.On or about on (b)(6) 2014 she started experiencing pain running up and down her leg, as well as a burning sensation.Patient had a left tka revision on (b)(6) 2016.Update as per received medical records: "this patient presented with repentance and patella femoral symptoms with tilting patella more than 15 degrees with superolateral pain and after informed consent, left knee arthroscopy with lateral release performed on 04/14/2016." no implants were revised.

• Brand Name: TRIATHLON SYMMETRIC X3 PATELLA
• 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: 7270186
• MDR Text Key: 100056915
• Report Number: 0002249697-2018-00415
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 5550-G-278
• Device Lot Number: 2TTV
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 58