MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON MB PATELLA PA A40; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5554L401
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Injury (2348); Limited Mobility Of The Implanted Joint (2671)
Date of Event	09/17/2019
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
It was reported the patient's left knee was revised.Intra-operatively, the poly portion of the metal- backed patella was found to have disassociated from the metal portion, and black tissue was noted in the patient.Surgeon confirmed with the rep that the femoral component did not appear to be damaged.The patellar device and liner were revised.It was not reported to the rep if there were any allegations against the liner - rep was not present for the procedure.Rep provided 1 intra- operative photo and reported that no further information will be available.
Additional Manufacturer Narrative
An event regarding disassociation and fretting involving a triathlon patella was reported.The event was confirmed.Method & results: device evaluation and results: the reported device was not returned however a photograph was provided for review.The photograph shows a recently explanted triathlon patella.From the photograph provided there is evidence of the poly portion of the metal-backed patella was disassociated from the metal portion and black tissue.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.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: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported the patient's left knee was revised.Intra-operatively, the poly portion of the metal- backed patella was found to have disassociated from the metal portion, and black tissue was noted in the patient.Surgeon confirmed with the rep that the femoral component did not appear to be damaged.The patellar device and liner were revised.It was not reported to the rep if there were any allegations against the liner - rep was not present for the procedure.Rep provided 1 intra- operative photo and reported that no further information will be available.

• Brand Name: TRIATHLON MB PATELLA PA A40
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9186525
• Report Number: 0002249697-2019-03491
• Device Sequence Number: 2811110
• Product Code: MBH
• UDI-Device Identifier: 07613327049923
• UDI-Public: 07613327049923
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019

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: 11/30/2019
• Device Catalogue Number: 5554L401
• Device Lot Number: EKF3F1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 133