MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-709-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	03/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: "patient had left tka.Following this procedure the patient had acute mental status changes and word finding difficulty.Mri brain showed a subdural hematoma for which the patient was evaluated by neurology.Repeat mri brain stable.Discharged to a rehab facility.During the afternoon of (b)(6) 2023, the patient was attempting to ambulate to the restroom and "woke up on the floor".He does not believe that he hit his head.He presented to the emergency department at university hospital on (b)(6) 2023 exhibiting some word finding difficulty.He did not hit head, no loc, no cp/sob immediately pre- or post- fall.The patient felt pain in left knee following the fall with traumatic arthrotomy and dehiscence of almost all of his surgical site.Patient was admitted to the hospital and underwent successful left knee washout procedure with liner change.The patient tolerated the procedure well and had an uneventful recovery.The patient decided that he wished to continue with warfarin as his current ac regiment rather than eliquis.He was planned for discharge on (b)(6) however was found to be significantly orthostatic.Possible offending medications including nortriptyline and flomax were discontinued and he was given compression stockings and abdominal binder however remained orthostatic.He was treated with ivf and echo was checked which was unremarkable.He continued to remain orthostatic but with minimal symptoms.As he is hypertensive to 160s while supine and seated he was not initiated on midodrine.He will be discharged back to rehab with antibiotics to be taken as instructed by orthopedics and to work with pt/ot to reduce risk of future falls.".
Additional Manufacturer Narrative
Reported event: an event regarding revision involving a triathlon insert 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 the 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 event could not be confirmed as insufficient information was provided.Further information such as device return, pre- and post-operative x-rays, 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 additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.

• Brand Name: X3 TRIATHLON CS INSERT #7 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 16797183
• Report Number: 0002249697-2023-00409
• Device Sequence Number: 3251561
• Product Code: MBH
• UDI-Device Identifier: 07613327337464
• UDI-Public: 07613327337464
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2023

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 Model Number: 5531-G-709-E
• Device Catalogue Number: 5531-G-709-E
• Device Lot Number: LM1P17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White