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

Model Number	5556-L-360
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event an event regarding size/fit issue involving a tritanium patella was reported.The event was not confirmed.Method & results product evaluation and results: material analysis, visual, 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.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: 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
Triathlon tritanium patella not able to be fully seated.Multiple attempts to fully seat including using press-fit clamp and button without success.Medial post sitting up and preventing the patella from sitting down nicely.The surgeon ended up having to cement a patella rather than press fit.Surgical delay: = 15 minutes.Case type / application: tka.Update: drills and templates used: mb drill bit with symmetric 36 patella template.Patient bone quality: very sclerotic, hard bone clamp used: tritanium patella clamp with symmetric 36 patella button followed by white tip patella clamp attachment on template/clamp handle as well as the circular clamp attachment.Patella implanted: the patella in question was not implanted.After unsuccessfully being seated, tritanium patella was removed and a symmetric cemented patella was implanted.The unsuccessfully implanted patella is now available for return.

• Brand Name: TRITANIUM PATELLA-SYMMETRIC
• 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: 11826892
• Report Number: 0002249697-2021-00857
• Device Sequence Number: 11873131
• Product Code: MBH
• UDI-Device Identifier: 07613327013511
• UDI-Public: 07613327013511
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: 5556-L-360
• Device Catalogue Number: 5556-L-360
• Device Lot Number: N43D1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/14/2021
• 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: Other