MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number 5537-G-311

Device Problem Insufficient Information (3190)

Patient Problems Scar Tissue (2060); Injury (2348); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/20/2013

Event Type  Injury  

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as an unknown right total knee.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Not returned to the manufacturer.

Event Description

It was reported by the patient's attorney through the filing of a legal claim that allegedly, the patient underwent a right total knee replacement on an unknown date.It is further alleged that the patient was then revised on (b)(6) 2013 due to impaired function of her knee.

Manufacturer Narrative

The following devices were also listed in this report: triathlon symmetric x3 patella; cat# 5550-g-278; lot# jvle.Triathlon ps fem comp #2r-cem; cat# 5515f202; lot# s4hkd.Tri cemented stem 12mmx50mm; cat# 5560-s-112; lot# n5n22d.Tri ts baseplate size 3; cat# 5521-b-300; lot# fsnp.Med howmedica bone plug 1pk; cat# 6215-5-011; lot# cpple05bh.Simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# mfs042.Simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# mfs042.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event regarding alleged arthrofibrosis involving a triathlon insert was reported.The event was confirmed.Medical records received and evaluation: a review of the primary and revision operative reports, office notes and x-ray printouts by the consulting clinician indicated "there is no examination of the explanted components, no description of wear or loosening of the components, and no evidence, either growth or histologic, of a description of adverse reaction to the primary total knee components.The clinical situation is typical of a diagnosis of reflex sympathetic dystrophy and arthrofibrosis, which apparently was not resolved by extensive revision surgery.There is no evidence this was related to factors of faulty primary total knee component design, manufacturing or materials." 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.Conclusions: the event was confirmed.However, the root cause could not be determined because the devices were not returned for evaluation and insufficient medical information was provided.A review of the primary and revision operative reports, office notes and x-ray printouts by the consulting clinician indicated "there is no examination of the explanted components, no description of wear or loosening of the components, and no evidence, either growth or histologic, of a description of adverse reaction to the primary total knee components.The clinical situation is typical of a diagnosis of reflex sympathetic dystrophy and arthrofibrosis, which apparently was not resolved by extensive revision surgery.There is no evidence this was related to factors of faulty primary total knee component design, manufacturing or materials." a trend analysis was conducted for the reported failure mode and concluded knee arthrofibrosis is most likely a result from other factors not necessarily related to the device in the healthcare facility setting.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

It was reported by the patient's attorney through the filing of a legal claim that allegedly, the patient underwent a right total knee replacement on an unknown date.It is further alleged that the patient was then revised on (b)(6) 2013 due to impaired function of her knee.Update: "the clinical situation is typical of a diagnosis of reflex sympathetic dystrophy and arthrofibrosis, which apparently was not resolved by extensive revision surgery.".

• Brand Name: NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 11MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 5130088
• MDR Text Key: 27565179
• Report Number: 0002249697-2015-03270
• 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: Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: 5537-G-311
• Device Lot Number: MHRJN0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 79