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

Catalog Number	5551-G-320-E
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	08/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon cr fem comp #4 r-cem; cat# 5510f402; lot# d2slu tri cemented stem 12mmx50mm; cat# 5560-s-112; lot# 1119327a x3 triathlon insert cs #5 14mm; cat# 5531-g-514-e; lot# 1312jh tri rm/ll tib aug sz5 5mm; cat# 5545-a-502; lot# xl73912a tri lm/rl tib aug sz5 5mm; cat# 5545-a-501; lot# xl76890a it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding periprosthetic fracture involving a triathlon patella was reported.The event was confirmed.Method & results: -device evaluation and results: visual inspection, material analysis, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of medical records with clinical consultant indicated " no operative or medical history were provided for review.By report the patient had a fall and sustained an extensor mechanism disruption, the x-rays confirm a displaced patella fracture.There is lucent line around the tibia.In the report the tibia was found to be loose.A spacer was placed but the rational for this procedure was not provided.It is unclear if the claim is that the tibia became loose from the fall.It is unclear it the tibia is a primary or a revision.Event confirmation: the event a patella fracture (extensor mechanism rupture) can be confirmed.A fall cannot be confirmed.A loose tibia cannot be confirmed although there are some radiographic findings that may indicate loosening.The rational for a spacer placement cannot be determined.Root cause: the root cause of the extensor mechanism rupture (patella fracture) would be the reported fall.The root cause of the reported loose tibia cannot be determined.-device history review: all 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 reported lot.Conclusion: a review of medical records with clinical consultant indicated " no operative or medical history were provided for review.By report the patient had a fall and sustained an extensor mechanism disruption, the x-rays confirm a displaced patella fracture.There is lucent line around the tibia.In the report the tibia was found to be loose.A spacer was placed but the rational for this procedure was not provided.It is unclear if the claim is that the tibia became loose from the fall.It is unclear it the tibia is a primary or a revision.Event confirmation: the event a patella fracture (extensor mechanism rupture) can be confirmed.A fall cannot be confirmed.A loose tibia cannot be confirmed although there are some radiographic findings that may indicate loosening.The rational for a spacer placement cannot be determined.Root cause: the root cause of the extensor mechanism rupture (patella fracture) would be the reported fall.The root cause of the reported loose tibia cannot be determined.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.Device not returned.
Event or Problem Description
Patient had a fall, ruptured extensor mechanism and loosening of the tibial component.Implants removed, cement spacer implanted.Right triathlon.Sales reps response confirms that all devices were removed.

• Brand Name: TRIATHLON ASYMMETRIC X3 PATELLA
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 18070546
• Report Number: 0002249697-2023-01327
• Device Sequence Number: 20787356
• Product Code: MBH
• UDI-Device Identifier: 07613327314649
• UDI-Public: 07613327314649
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/04/2023

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 Catalogue Number: 5551-G-320-E
• Device Lot Number: AKXE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 11/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2022
• 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: 83 KG