MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI PRESS-FIT STEM 10MM X 100MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5565-S-012
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device evaluated by manufacturer? device not available.
Event or Problem Description
Revision left total knee replacement.Removed triathlon universal baseplate & fluted stem & ps insert for loosening.Revised with triathlon universal baseplate, cemented tibial stem & ts insert.Previous revision surgery conducted at (b)(6) in (b)(6) 2014.
Additional Manufacturer Narrative
Corrected data: catalog, lot, expiration date, manufacturing date.An event regarding loosening involving a triathlon stem was reported.The event was not confirmed.Method & results: -device evaluation and results: he reported device was not returned however a photograph was provided for review.The photograph shows a recently explanted baseplate with a stem component still attached.From the photograph provided there is no evidence of damage noted.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; clear primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.-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 revision surgery took place due to loosening of the tibial components.The event could not be confirmed with the information provided.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including clear primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Revision left total knee replacement.Removed triathlon universal baseplate & fluted stem & ps insert for loosening.Revised with triathlon universal baseplate, cemented tibial stem & ts insert.Previous revision surgery conducted at (b)(6) in (b)(6) 2014.

• Brand Name: TRI PRESS-FIT STEM 10MM X 100MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8892301
• Report Number: 0002249697-2019-02835
• Device Sequence Number: 19222841
• Product Code: MBH
• UDI-Device Identifier: 07613327026771
• UDI-Public: 07613327026771
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2023

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: 03/10/2019
• Device Model Number: 5565-S-012
• Device Catalogue Number: 5565-S-010
• Device Lot Number: M9C25H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 105 KG