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

Model Number	5550-G-278-E
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.Not returned.
Event or Problem Description
Patient who previously had a mako total knee replacement had a fall and fractured patella.Replacement patella was implanted.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving a triathlon patella was reported.The event was confirmed by clinician review.Method & results: device evaluation and results: the device was not received.Visual inspection for the provided intra-op images noted the host patella fractured.Nothing can be observed about the device.Dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated that," 2 undated intra-operative color photos of fractured host patella pre-repair and post-revision.Undated x-rays lateral and patellar views left knee : uncemented tka with fracture of host patella with dislocation of metal backed, uncemented patellar component.No clinical or pmh, no patient demographics, no operative reports, no dated serial x-rays, no examination explanted components.Based upon the information supplied, confirmation of the event description is possible, but insufficient data is presented to create a medical report for this case." 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: it was reported that the patient's knee was revised after the patient had a fall and fractured patella.Visual inspection for the provided intra-op images noted the host patella fractured.Nothing can be observed about the device.A review of the provided medical records by a clinical consultant stated that, the clinician reviewed 2 undated intra-operative color photos of fractured host patella pre-repair and post-revision.Undated x-rays lateral and patellar views left knee : uncemented tka with fracture of host patella with dislocation of metal backed, uncemented patellar component.No clinical or pmh, no patient demographics, no operative reports, no dated serial x-rays, no examination explanted components.Based upon the information supplied, confirmation of the event description is possible, but insufficient data is presented to create a medical report for this case.The exact cause could not be determined because insufficient information was provided.Additional information including operative reports, progress notes are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.
Event or Problem Description
Patient who previously had a mako total knee replacement had a fall and fractured patella.Replacement patella was implanted.

• 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
• MDR Report Key: 10828298
• Report Number: 0002249697-2020-02424
• Device Sequence Number: 1767796
• Product Code: MBH
• UDI-Device Identifier: 07613327314823
• UDI-Public: 07613327314823
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: 03/31/2025
• Device Model Number: 5550-G-278-E
• Device Catalogue Number: 5552-L-320
• Device Lot Number: LHNE1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 01/25/2021
• 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: 67 YR