MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 4 TRIATH TS PLUS TIB INS X3 POLY 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-411
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	05/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding range of motion (rom) involving a triathlon insert was reported.The event was confirmed via medical review.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a revision right total knee arthroplasty in sometime in (b)(6) 2019 since i was able to see x-rays of the revision implant and was able to construct a timeline based on office visits.I did not have the revision operation report.I can confirm that the patient underwent manipulation at about six weeks after surgery for stiffness.No other information about this patient was given.Root cause analysis: the root cause of this event cannot be determined with certainty.Stiffness following revision total knee arthroplasty is not unusual and manipulation often becomes necessary.Causes of stiffness are multifactorial including surgical technique, especially in the restoration of kinematics, with proper positioning, sizing, and alignment, patient factors including lifestyle, compliance with the postoperative therapy regime, activity level and bmi also contribute.There are patients who are prone to forming scar tissue as well.I would not attribute any causality to the implant itself." 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: it as reported that the patient underwent a mua (manipulation under anesthesia_ due to limited range of motion.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a revision right total knee arthroplasty in sometime in (b)(6) 2019 since i was able to see x-rays of the revision implant and was able to construct a timeline based on office visits.I did not have the revision operation report.I can confirm that the patient underwent manipulation at about six weeks after surgery for stiffness.No other information about this patient was given.Root cause analysis: the root cause of this event cannot be determined with certainty.Stiffness following revision total knee arthroplasty is not unusual and manipulation often becomes necessary.Causes of stiffness are multifactorial including surgical technique, especially in the restoration of kinematics, with proper positioning, sizing, and alignment, patient factors including lifestyle, compliance with the postoperative therapy regime, activity level and bmi also contribute.There are patients who are prone to forming scar tissue as well.I would not attribute any causality to the implant itself." 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.The following devices were also listed in this report: device name# tri ts femur sz5 right; cat#5512-f-502; lot# dgr3x.Device name# tri ts baseplate size 4; cat#5521-b-400; lot# dou7eb.Device name# triathlon sym cone aug sz a; cat#5549-a-110; lot# e8k6.Device name# triathlon asymmetric x3 patella; cat#5551-g-320; lot# rntp.Device name# tri cemented stem 12mmx50mm; cat#5560-s-112; lot# 0083085m.Device name# triathlon cemented stem-15mm x 50mm; cat#5560-s-115; lot# 0084084d.Device name# tri rm/ll tib aug sz4 5mm; cat#5545-a-402; lot# erdwk0a.Device name# tri lm/rl tib aug sz4 5mm; cat#5545-a-401; lot# erdtn5d.Device name# tri post augment sz5 5mm; cat#5543-a-500; lot# dgv3d.Device name# triath fem distal aug 5mm - size 5 right; cat# 5540-a-502; lot# dhx7a.Device name# triath fem distal aug 5mm - size 5 right; cat# 5540-a-502; lot# dhx7a.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Subject had a revision surgery of competitor components with stryker cone augments as part of the 76 triathlon cones study.Subject required a manipulation under anesthesia for limited range of motion which resolved following the mua on (b)(6) 2019.

• Brand Name: NO 4 TRIATH TS PLUS TIB INS X3 POLY 11MM
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20885506
• Report Number: 0002249697-2024-01679
• Device Sequence Number: 8934196
• Product Code: MBH
• UDI-Device Identifier: 07613327027228
• UDI-Public: 07613327027228
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2024

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: 11/30/2023
• Device Catalogue Number: 5537-G-411
• Device Lot Number: 6X5NLV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White