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

Catalog Number	5554L381
Medical Device Problem Codes	Degraded (1153); Material Separation (1562)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	09/27/2018
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer however, explant photos show wear and separation of the device.Without additional information the root cause for this event cannot be established.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
It was reported that patient's right knee was revised due to pain.
Additional Manufacturer Narrative
An event regarding patellar disassociation involving a triathlon mb patellar component was reported.The event was confirmed based on visual inspection of the photo of the component provided.Method & results: -device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted metal backed patellar component with the poly and the metal backing separated.From the photographs provided there is what appears to be bone/soft tissue attached to the porous coated side of the component.There are marks evident on the bearing part of the poly.-medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: complex malalignment of components including an oblique joint space between femur and tibia, likely femoral rotatory malposition and patellofemoral malalignment with lateral tilt/shift have contributed to an overload condition in the pf joint resulting ultimately in disassociation between patellar metal-backing and poly requiring revision surgery.Tibio-femoral instability was possibly an additional but secondary indicator for revision as caused by the oblique joint space with tibial bearing wear, not explicitly evident from the available documentation.-device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant indicated: complex malalignment of components including an oblique joint space between femur and tibia, likely femoral rotatory malposition and patellofemoral malalignment with lateral tilt/shift have contributed to an overload condition in the pf joint resulting ultimately in disassociation between patellar metal-backing and poly requiring revision surgery.Tibio-femoral instability was possibly an additional but secondary indicator for revision as caused by the oblique joint space with tibial bearing wear, not explicitly evident from the available documentation.Further information such as product evaluation, ct scans, revision operative reports, patient history, follow-up notes are needed to complete the investigation for determining a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that patient's right knee was revised due to pain.Update 4 dec2 018: complex malalignment of components including an oblique joint space between femur and tibia, likely femoral rotatory malposition and patellofemoral malalignment with lateral tilt/shift have contributed to an overload condition in the pf joint resulting ultimately in disassociation between patellar metal-backing and poly requiring revision surgery.

• 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
• MDR Report Key: 8006233
• Report Number: 0002249697-2018-03503
• Device Sequence Number: 10835115
• 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: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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: 11/30/2015
• Device Catalogue Number: 5554L381
• Device Lot Number: SNLLJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 MO
• Patient Weight: 93