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

Model Number	5532-G-511
Medical Device Problem Codes	Unstable (1667); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Joint Laxity (4526)
Date of Event	07/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, 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 relevant reported discrepancies.There have been no other similar events for the lot referenced.Device not returned to the manufacturer.
Event or Problem Description
Patient reported dissatisfaction with their knee replacement.Additional comments: "knee rocks side becomes sore.Clicks; can't kneel down." coordinator notes that poly exchange was recommended and notes: "i contacted the patient and he seems to have a lot of fears/ concerns about the procedure and if he¿ll get better or have the same outcome.He is considering having a revision in january and will call when he¿s ready." patient indicated not to have had surgery on the knee.
Event or Problem Description
Patient reported dissatisfaction with their knee replacement.Additional comments: "knee rocks side - becomes sore.Clicks; can't kneel down." coordinator notes that poly exchange was recommended and notes: "i contacted the patient and he seems to have a lot of fears/ concerns about the procedure and if he¿ll get better or have the same outcome.He is considering having a revision in january and will call when he¿s ready." patient indicated not to have had surgery on the knee.Update: as reported via clinical support: the subject was enrolled in the triathlon tritanium knee outcomes study on (b)(6) 2015.During stryker site visit on (b)(6) 2023, the clinical monitor learned that this study subject underwent a revision of the knee on (b)(6) 2023 due to ¿right knee prosthetic mechanical instability.¿ the subject presented in the clinic on (b)(6) 2022 and according to the pi ¿complained of right knee instability.¿ an x-ray of right knee showed ¿well fixed total knee replacement with no evidence of loosening or wear.¿ a recommendation for knee revision surgery was made on ¿the patient¿s pain, function and bone stock.¿ update: confirmed that only the tibial insert was revised.
Additional Manufacturer Narrative
An event regarding instability 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 " conclusion/assessment: a revision surgery was performed for instability in a well fixed uncemented triathlon tka.The instability presented early in the post primary course but was not revised until 6.5 yrs.Later.Event confirmation: a revision surgery for knee instability can be confirmed.Root cause: the root cause of the revision was knee instability.The root cause of the instability cannot be ascertained." product history review: review of the device history records indicates 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 " conclusion/assessment: a revision surgery was performed for instability in a well fixed uncemented triathlon tka.The instability presented early in the post primary course but was not revised until 6.5 yrs.Later.Event confirmation: a revision surgery for knee instability can be confirmed.Root cause: the root cause of the revision was knee instability.The root cause of the instability cannot be ascertained." 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 PS 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14167171
• Report Number: 0002249697-2022-00566
• Device Sequence Number: 12245596
• Product Code: MBH
• UDI-Device Identifier: 07613327050783
• UDI-Public: 07613327050783
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K051146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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: 06/30/2020
• Device Model Number: 5532-G-511
• Device Catalogue Number: 5532-G-511
• Device Lot Number: KM5AX8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2015
• 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: Required Intervention; Other; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White