MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-313-E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Patient reported a primary right knee replacement on (b)(6) 2022 and a revision on (b)(6) 2022 due to "locking device plate & bushing" broke.Patient reported the surgeon removed a "round plastic disk" which allegedly broke in half.Patient claimed no specific trauma prior to revision.
Event or Problem Description
Patient reported a primary right knee replacement on (b)(6), 2022 and a revision on (b)(6), 2022 due to "locking device plate & bushing" broke.Patient reported the surgeon removed a "round plastic disk" which allegedly broke in half.Patient claimed no specific trauma prior to revision.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon insert was reported.The event was confirmed via review of the provided medical records.Method & results: -device 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 provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to including the product inquiry summary, an operative report from the revision tka surgery as well as limited medical records related to this surgery.The event description from the product inquiries summary states: patient reported a primary right knee replacement on (b)(6), 2022 and a revision on (b)(6), 2022 due to "locking device plate & bushing" broke.Patient reported the surgeon removed a "round plastic disk" which allegedly broke in half.Patient claimed no specific trauma prior to revision.Patient wanted to know what the "warranty" was on the parts and wants to know if cost can be covered.The operative report confirms that a revision surgery was performed on (b)(6) 2022.The reason for the revision is that the locking mechanism for the ts insert had failed, the insert came loose and had fractured.Although the root cause for this failure cannot be discerned from this limited information it should be noted that the operative report denoted that the patient had a high bmi of 46.9 which could be contributory.Should additional information become available i would be happy to further this assessment.-device 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.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to including the product inquiry summary, an operative report from the revision tka surgery as well as limited medical records related to this surgery.The event description from the product inquiries summary states: patient reported a primary right knee replacement on (b)(6), 2022 and a revision on (b)(6), 2022 due to "locking device plate & bushing" broke.Patient reported the surgeon removed a "round plastic disk" which allegedly broke in half.Patient claimed no specific trauma prior to revision.Patient wanted to know what the "warranty" was on the parts and wants to know if cost can be covered.The operative report confirms that a revision surgery was performed on (b)(6) 2022.The reason for the revision is that the locking mechanism for the ts insert had failed, the insert came loose and had fractured.Although the root cause for this failure cannot be discerned from this limited information it should be noted that the operative report denoted that the patient had a high bmi of 46.9 which could be contributory.Should additional information become available i would be happy to further this assessment.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15063702
• Report Number: 0002249697-2022-01051
• Device Sequence Number: 5425617
• Product Code: MBH
• UDI-Device Identifier: 07613327287974
• UDI-Public: 07613327287974
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2022

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: 01/31/2026
• Device Model Number: 5537-G-313-E
• Device Catalogue Number: 5537-G-313-E
• Device Lot Number: RE2X9D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 10/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 120 KG