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

Catalog Number	5552-L-401
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.
Event or Problem Description
Revision on tritanium patella.Loose in bone.Surgeon used cemented patella for revision.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a triathlon patella was reported.The event was confirmed via clinician review of the provided medical records.Method & results: -product evaluation and results: the device was not returned; however, a photograph was provided for review.The photograph shows a patellar component that is covered bodily matter.Nothing remarkable can be seen in the photo.-clinician review: a review of the provided medical information by a clinical consultant indicated: "the records including the lateral view x-ray showing gross loosening of a patella component confirm loss of component fixation.Implant records confirm a revision of the patella component and tibial liner was performed.The root cause of this failure of fixation can not be determined from the information provided." -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 loosening of the patellar component.The device was not returned; however, a photograph was provided for review.The photograph shows a patellar component that is covered bodily matter.Nothing remarkable can be seen in the photo.A review of the provided medical information by a clinical consultant indicated: "the records including the lateral view x-ray showing gross loosening of a patella component confirm loss of component fixation.Implant records confirm a revision of the patella component and tibial liner was performed.The root cause of this failure of fixation can not be determined from the information provided." 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
Revision on tritanium patella.Loose in bone.Surgeon used cemented patella for revision.

• Brand Name: TRITANIUM PATELLA-ASYMMETRIC
• 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 18352869
• Report Number: 0002249697-2023-01577
• Device Sequence Number: 8416087
• Product Code: MBH
• UDI-Device Identifier: 07613327013573
• UDI-Public: 07613327013573
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• 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,Followup
• Report Date (Section B): 03/22/2024

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: 5552-L-401
• Device Lot Number: Y52H1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2021
• 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: 62 YR
• Patient Sex: Male