MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CS INS SIZE 4 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531P409
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Fibrosis (3167); Joint Laxity (4526); Muscle/Tendon Damage (4532)
Date of Event	06/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: cat# 5520-b-400; triathlon prim tib bplate cemented sz 4; lot# htdla cat# 5510f501; triathlon cr fem comp #5 l-cem; lot# unknown it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient seeing dr.For left knee increasing pain, instability and stiffness.Revision surgery occurred on (b)(6) 2018 which included quadricep release/quadricepsplasty.
Event or Problem Description
Patient seeing dr.For left knee increasing pain, instability and stiffness.Revision surgery occurred on (b)(6) 2018 which included quadricep release/quadricepsplasty.
Additional Manufacturer Narrative
An event regarding instability and arthrofibrosis involving a triathlon insert was reported.The event was confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of medical records with a clinical consultant indicated "confirmation of event: i can confirm that the patient underwent a primary cemented triathlon cr total knee arthroplasty since i was able to see x-rays with that implant in place.I am also able to confirm the revision surgery since i was able to review the revision operation report.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of instability five at half years following the index surgery are multifactorial including initial surgical technique, patient activity level and bmi, whether or not trauma was involved, and the possibility of stretching of the ligament complexes that result in instability.Causes of arthrofibrosis are also multifactorial including surgical technique, especially in sizing and positioning of the implants, with a cr implant, the posterior cruciate ligament must be addressed for tightness and competency, patient factors including noncompliance with a postoperative regime and inherent patient ability to form scar tissue.While no specific range of motion was given, and the revision procedure the knee was described as "stuck" with the quadriceps resting on the implant.However once the scar tissue was removed the surgeon stated there was no instability.".Product history review: review of the device history records indicate 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 lot referenced.Conclusions: a review of medical records with a clinical consultant indicated "confirmation of event: i can confirm that the patient underwent a primary cemented triathlon cr total knee arthroplasty since i was able to see x-rays with that implant in place.I am also able to confirm the revision surgery since i was able to review the revision operation report.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of instability five at half years following the index surgery are multifactorial including initial surgical technique, patient activity level and bmi, whether or not trauma was involved, and the possibility of stretching of the ligament complexes that result in instability.Causes of arthrofibrosis are also multifactorial including surgical technique, especially in sizing and positioning of the implants, with a cr implant, the posterior cruciate ligament must be addressed for tightness and competency, patient factors including noncompliance with a postoperative regime and inherent patient ability to form scar tissue.While no specific range of motion was given, and the revision procedure the knee was described as "stuck" with the quadriceps resting on the implant.However once the scar tissue was removed the surgeon stated there was no instability.".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 record will be reopened.

• Brand Name: TRIATHLON CS INS SIZE 4 9MM
• Common Device Name: 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 ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19526495
• Report Number: 0002249697-2024-00875
• Device Sequence Number: 7606073
• Product Code: MBH
• UDI-Device Identifier: 07613327042238
• UDI-Public: 07613327042238
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 5531P409
• Device Lot Number: LCY273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White