MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5520-B-400
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding subsidence involving a triathlon baseplate was reported.The event was not confirmed.Method & results: device evaluation and results: material analysis , visual inspection, functional and dimensional inspections could not be performed because 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 event was not confirmed for subsidence.The exact cause of the event could not be determined because insufficient information was provided.Additional information including device return , clinical and past medical history, post op x- rays and examination of explanted components are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.Device not returned.
Event or Problem Description
Cemented tibia appears to have subsided requiring a revision of the tibia component only.Update: "there is no information available regarding which cement was used for the primary procedure.The insert explanted showed no unusual signs of wear.The locking mechanism was intact and had to be broken to remove the insert.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• 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: 11816980
• Report Number: 0002249697-2021-00843
• Device Sequence Number: 3792899
• Product Code: MBH
• UDI-Device Identifier: 07613327050325
• UDI-Public: 07613327050325
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2021

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: 09/30/2013
• Device Model Number: 5520-B-400
• Device Catalogue Number: 5520-B-400
• Device Lot Number: YULX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/13/2021
• 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: 75 YR
• Patient Weight: 127