MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BPLATE CEMENTED SZ 3; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5520-B-300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient fell down and fractured her knee.Primary ltkr was done on (b)(6) 2023.Now booking for ltkr revision on (b)(6) 2024.
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.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving a triathlon baseplate 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 with a clinical consultant indicated "the x-rays reviewed demonstrate a periprosthetic tibial fracture with gross displacement of the tibial component.Periprosthetic tibial fracture is confirmed.No documentation was provided regarding the revision surgery.In the event description it is stated that the root cause of this fracture was "a fall" should further documentation become available i would be happy to further this investigation." -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 was revised due to periprosthetic fracture of the tibia.A review with a clinical consultant indicated "the x-rays reviewed demonstrate a periprosthetic tibial fracture with gross displacement of the tibial component.Periprosthetic tibial fracture is confirmed.No documentation was provided regarding the revision surgery.In the event description it is stated that the root cause of this fracture was "a fall" should further documentation become available i would be happy to further this investigation." 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.
Event or Problem Description
It was reported that patient fell down and fractured her knee.Primary ltkr was done on (b)(6) 2023.Now booking for ltkr revision on (b)(6) 2024.Update: patient was revised on (b)(6) 2024.

• Brand Name: TRIATHLON PRIM TIB BPLATE CEMENTED SZ 3
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19360205
• Report Number: 0002249697-2024-00771
• Device Sequence Number: 15078209
• Product Code: MBH
• UDI-Device Identifier: 07613327050318
• UDI-Public: 07613327050318
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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 Catalogue Number: 5520-B-300
• Device Lot Number: Y674T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2023
• 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; Other
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Race: Asian