MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S3; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5536B300
Medical Device Problem Codes	Fracture (1260); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left knee was revised due to pain and suspected bone loosening based on indications seen in bone scan.Intra-operatively, the implants did not appear to be grossly loose.A tibial baseplate and insert were revised.Rep confirmed there were no allegations against the revised insert.
Additional Manufacturer Narrative
Reported event: an event regarding loosening and fracture involving a triathlon baseplate was reported.The event was confirmed.Method & results: -product evaluation and results: the device was not returned; however, photographs were provided for review.The photographs show a recently explanted baseplate, covered in blood.It was also observed that two small pieces had fractured off of the baseplate.-clinician review: a review of the provided medical records by a clinical consultant indicated: "it was reported that the patient's left knee was revised due to pain and suspected bone loosening (based on indications seen in bone scan).Intra-operatively, the implants did not appear to be grossly loose.A tibial baseplate and insert were revised.Rep confirmed there were no allegations against the revised insert.Rep may be able to provide additional images, otherwise confirmed no further information will be released by the hospital or surgeon.The x-rays show a pressfit tka in anatomic alignment.On the lateral view there is a suggestion lucemcy beneath the baseplate.In addition anterior to the baseplate is a small amount of reactive bone formation.These findings are consistent with early loosening.Early loosening of a tibial component in a pressfit tka is confirmed.No documentation was provided to confirm a revision tla surgery occurred.The root cause of this early tibial loosening cannot be determined from the limited documentation provided.Should additional information become available i would be happy to further this assessment." -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 patient was revised due to baseplate loosening.The device was not returned; however, photographs were provided for review.The photographs show a recently explanted baseplate, covered in blood.It was also observed that two small pieces had fractured off of the baseplate.A review of the provided medical records by a clinical consultant indicated: "it was reported that the patient's left knee was revised due to pain and suspected bone loosening (based on indications seen in bone scan).Intra-operatively, the implants did not appear to be grossly loose.A tibial baseplate and insert were revised.Rep confirmed there were no allegations against the revised insert.Rep may be able to provide additional images, otherwise confirmed no further information will be released by the hospital or surgeon.The x-rays show a pressfit tka in anatomic alignment.On the lateral view there is a suggestion lucemcy beneath the baseplate.In addition anterior to the baseplate is a small amount of reactive bone formation.These findings are consistent with early loosening.Early loosening of a tibial component in a pressfit tka is confirmed.No documentation was provided to confirm a revision tla surgery occurred.The root cause of this early tibial loosening cannot be determined from the limited documentation provided.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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned to the manufacturer.

• Brand Name: TRITANIUM BPLATE TRIATHLON S3
• 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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18048621
• Report Number: 0002249697-2023-01302
• Device Sequence Number: 18017364
• Product Code: MBH
• UDI-Device Identifier: 07613327041484
• UDI-Public: 07613327041484
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K123486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2023

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: 5536B300
• Device Lot Number: CTD70368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 69 KG