MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #4 PS INSERT 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5532-P-409
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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
It was reported by the sales rep that surgeon informed that medial laxity and hyperextension when patient extend his leg detected through clinical finding upon clinic appointment.Explanted done and replaced with ts implants ( revision surgery) this is a first revision surgery , the primary surgery was done on (b)(6) 2020.Patient outcome ( as of 25 may 2022) : as the revision surgery just been done, patient is recovering well.
Event or Problem Description
It was reported by the sales rep that surgeon informed that medial laxity and hyperextension when patient extend his leg detected through clinical finding upon clinic appointment.Explanted done and replaced with ts implants ( revision surgery).This is a first revision surgery, the primary surgery was done on (b)(6) 2020.Patient outcome ( as of (b)(6) 2022) : as the revision surgery just been done, patient is recovering well.
Additional Manufacturer Narrative
Reported event: an event regarding instability involving a triathlon insert was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection: the devices were not returned however photographs were provided for review.A review of the photographs indicated recently explanted devices covered in blood and tissue.The locking wire of the insert was fractured off consistent with explantation.Nothing remarkable is observed.Material analysis, 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.

• Brand Name: TRIATHLON #4 PS INSERT 9MM
• 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-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 14700882
• Report Number: 0002249697-2022-00844
• Device Sequence Number: 11296576
• Product Code: MBH
• UDI-Device Identifier: 07613327042764
• UDI-Public: 07613327042764
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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: 06/30/2024
• Device Model Number: 5532-P-409
• Device Catalogue Number: 5532P409
• Device Lot Number: M44L6H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2019
• 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 Sex: Unknown