MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON MB PATELLA PA A38; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5554-L-381
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988); Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/14/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patient's right knee was revised.As reported: "knee pain and grinding." a 9x3 cr insert and a38 beaded patella were revised.
Additional Manufacturer Narrative
An event regarding dislocation involving a triathlon patella was reported.The event was confirmed via medical review.Method & results: product evaluation and results: visual inspection of the provided photographs indicated blood on surface and fractures occurred during explantation.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of medical records with a clinical consultant indicated "the 11/16/201 operative report describes standard uncomplicated primary surgeries.The single ap x-ray demonstrates a patellar component in abnormally superior position in relationship to the femoral component and the joint line.No confirmative lateral view was available.Following review of this limited documentation neither revision surgery nor the root cause for the high riding patella can be established or confirmed." -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: a review of medical records with a clinical consultant indicated "the 11/16/201 operative report describes standard uncomplicated primary surgeries.The single ap x-ray demonstrates a patellar component in abnormally superior position in relationship to the femoral component and the joint line.No confirmative lateral view was available.Following review of this limited documentation neither revision surgery nor the root cause for the high riding patella can be established or confirmed." the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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 the patient's right knee was revised.As reported: "knee pain and grinding." a 9x3 cr insert and a38 beaded patella were revised.

• Brand Name: TRIATHLON MB PATELLA PA A38
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14030115
• Report Number: 0002249697-2022-00481
• Device Sequence Number: 4610017
• Product Code: MBH
• UDI-Device Identifier: 07613327049916
• UDI-Public: 07613327049916
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K061521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2022

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: 06/30/2015
• Device Model Number: 5554-L-381
• Device Catalogue Number: 5554L381
• Device Lot Number: SR8TM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2010
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 92 KG