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

Model Number	5530-G-711
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	12/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported revision due to infection.Patient alleges a triathlon right knee was implanted on (b)(6) 2019 with the use of triathlon cutting guide.Patient reported a 1st stage revision in (b)(6) 2019 with irrigation & debridement where all parts were removed.Patient reported the 2nd stage revision in (b)(6) 2020 (noting "all parts removed").Patient noted competitor product was implanted in 2021 and has had multiple surgeries since.Patient noted "extreme financial loss, quality of life, pain".Patient would like to know if any stryker parts are subject to a recall.Patient alleges a "shapematch" cutting guide was used.This pi is for i&d & poly swap performed on (b)(6) 2019.
Additional 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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.The following devices were also listed in this report: triathlon p/a cr beaded #7r; cat# 5517f702; lot# cpx2s.Tritanium bplate triathlon s7; cat# 5536b700; lot# ctd34017.Tritanium patella-asymmetric; cat# 5552-l-401; lot# em58.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Additional Manufacturer Narrative
Corrected data: date of explant.An event regarding infection 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 was not returned.-clinician review: a review of the medical records by clinical consultant indicated " it is confirmed that the patient had a stryker triathlon knee implanted and that at an early post-operative time frame he developed a prosthetic joint infection.It is further confirmed that he subsequently underwent multiple surgeries including an i&d with liner exchange and subsequently a two stage revision and multiple courses of antibiotics.The root cause of this issue can not be established.Infection is a relatively rare but well known risk of joint replacement surgery." -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 has been no other similar event for the lot and sterile lot referenced.Conclusions: it was reported that the patient was revised due to infection.A review of the medical records by clinical consultant indicated " it is confirmed that the patient had a stryker triathlon knee implanted and that at an early post-operative time frame he developed a prosthetic joint infection.It is further confirmed that he subsequently underwent multiple surgeries including an i&d with liner exchange and subsequently a two stage revision and multiple courses of antibiotics.The root cause of this issue can not be established.Infection is a relatively rare but well known risk of joint replacement surgery." all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient reported revision due to infection.Patient alleges a triathlon right knee was implanted on (b)(6), 2019 with the use of triathlon cutting guide.Patient reported a 1st stage revision in (b)(6) 2019 with irrigation & debridement where all parts were removed.Patient reported the 2nd stage revision in (b)(6) 2020 (noting "all parts removed").Patient noted competitor product was implanted in 2021 and has had multiple surgeries since.Patient noted "extreme financial loss, quality of life, pain".Patient would like to know if any stryker parts are subject to a recall.Patient alleges a "shapematch" cutting guide was used.This pi is for i&d & poly swap performed on (b)(6), 2019.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• 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: 14838354
• Report Number: 0002249697-2022-00929
• Device Sequence Number: 2367562
• Product Code: MBH
• UDI-Device Identifier: 07613327045499
• UDI-Public: 07613327045499
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

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: 01/06/2021
• Device Model Number: 5530-G-711
• Device Catalogue Number: 5530-G-711
• Device Lot Number: LEU296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2016
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 122 KG