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

Model Number	5552-L-299
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	03/11/2020
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.
Event or Problem Description
Update may 15, 2020 for issues after left knee revision: revision surgery was performed by cement patella on (b)(6), but the left knee has recurred after the revision.The patient has refused re-operation, so it is being followed up.On (b)(6) patella fractured after both knees tka.Tritanium patella was used.Doctors are new to this, and the cause is unknown.Revision scheduled for (b)(6).
Additional Manufacturer Narrative
Updated the implant date.Reported event: an event regarding periprosthetic fracture involving tritanium patella was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not remains implanted.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: re pi- which represents an additional pi for the other 2 pis for which i rejected a report for this patient.The event description alludes to a revision of an uncemented patellar component to a cemented component with persistence of clinical problems.No additional documentation is presented for this pi and therefore confirmation of the event description and preparation of a report is not possible.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: re pi - which represents an additional pi for the other 2 pis for which i rejected a report for this patient.The event description alludes to a revision of an uncemented patellar component to a cemented component with persistence of clinical problems.No additional documentation is presented for this pi and therefore confirmation of the event description and preparation of a report is not possible.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.H3 other text: device not returned.
Event or Problem Description
Updated (b)(6) 2020 for issues after left knee revision: revision surgery was performed by cement patella on (b)(6), but the left knee has recurred after the revision.The patient has refused re-operation, so it is being followed up.On (b)(6), patella fractured after both knees tka.Tritanium patella was used.Doctors are new to this, and the cause is unknown.Revision scheduled for (b)(6).

• 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: 10130665
• Report Number: 0002249697-2020-01097
• Device Sequence Number: 3361174
• Product Code: MBH
• UDI-Device Identifier: 07613327013535
• UDI-Public: 07613327013535
• Combination Product (Y/N): N
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

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 Model Number: 5552-L-299
• Device Catalogue Number: 5552-L-299
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 08/21/2020
• 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