MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 2 TRIATH TS PLUS TIB INS X3 POLY 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-209
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following device was also listed in this report: device; tri ts femur sz2 right ; cat# 5512-f-202 ; lot# tezs.Device; tri ts baseplate size 2 ; cat# 5521-b-200 ; lot# sobed.Device; tri cemented stem 12mmx50mm ; cat# 5560-s-112 ; lot# 0040777l.Device; tri cemented stem 12mmx50mm ; cat# 5560-s-112 ; lot# 0033967k.Device; triathlon sym cone aug sz a ; cat# 5549-a-110 ; lot# a8t6.Device; tri rm/ll tib aug sz2 10mm ; cat# 5546-a-202 ; lot# mc7h04e.Device; tri lm/rl tib aug sz2 10mm ; cat# 5546-a-201 ; lot# mc7t01a.Device; triath fem distal aug 5mm - size 2 right ; cat# 5540-a-202 ; lot# ktpr.Device; triath fem distal aug 5mm - size 2 right ; cat# 5540-a-202 ; lot# jgst.Device; tri post augment sz2 5mm ; cat# 5543-a-200 ; lot# svbz.Device; tri post augment sz2 5mm ; cat# 5543-a-200 ; lot# svbz.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.
Event or Problem Description
Subject (b)(6) came into the office for their 8yr visit for the sss 76 cones study.Subject completed study follow-up questionnaire (fupq) and radiographs were taken.During the visit subject expressed to dr.Having knee pain, pain on both sides of the knee.For question #5 "are you satisified with the results of your study knee replacement?", subject answered "no, i feel like too much pain".Per email correspondence on (b)(6) 2024, dr.Confirmed the knee pain is not related to the implants and is related to patient chronic pain post op.
Additional Manufacturer Narrative
Reported event: an event regarding pain involving a triathlon insert was reported.The event was not confirmed.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 total knee arthroplasty but i cannot confirm the date.The radiographs that i saw have no date and no patient identification.According to the product inquiry the patient had her surgery in 2016.The surgeon¿s office visit does state that the patient had a revision total knee arthroplasty.The root cause of this patient's pain cannot be determined with certainty.Chronic pain following revision total knee arthroplasty is multifactorial including surgical technique, possible loosening, possible infection, possible impingement, soft tissue issues etc.Without a workup for the painful joint no specific reason can be given.Also contributing would be the patient's activity level and bmi.With the information provided i would not assign any cause 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 was reported that the patient is experiencing pain post-implantation.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a revision total knee arthroplasty but i cannot confirm the date.The radiographs that i saw have no date and no patient identification.According to the product inquiry the patient had her surgery in 2016.The surgeon¿s office visit does state that the patient had a revision total knee arthroplasty.The root cause of this patient's pain cannot be determined with certainty.Chronic pain following revision total knee arthroplasty is multifactorial including surgical technique, possible loosening, possible infection, possible impingement, soft tissue issues etc.Without a workup for the painful joint no specific reason can be given.Also contributing would be the patient's activity level and bmi.With the information provided i would not assign any cause to the implant itself." the exact cause could not be determined at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Subject (b)(6) came into the office for their 8yr visit for the sss 76 cones study.Subject completed study follow-up questionnaire (fupq) and radiographs were taken.During the visit subject expressed to dr.Having knee pain, pain on both sides of the knee.For question #5 "are you satisified with the results of your study knee replacement?", subject answered "no, i feel like too much pain".Per email correspondence on 5/10/24, dr.Confirmed the knee pain is not related to the implants and is related to patient chronic pain post op.

• Brand Name: NO 2 TRIATH TS PLUS TIB INS X3 POLY 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19408871
• Report Number: 0002249697-2024-00808
• Device Sequence Number: 8338400
• Product Code: MBH
• UDI-Device Identifier: 07613327027037
• UDI-Public: 07613327027037
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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: 04/30/2020
• Device Catalogue Number: 5537-G-209
• Device Lot Number: YH4H67
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 09/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2015
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White