MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CS NUM6 10MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531-G-610-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Fluid Discharge (2686)
Date of Event	11/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.H3 other text : device not returned to the manufacturer.
Event or Problem Description
It was reported that the patient's left knee was revised due to inflammation and drainage.It did not appear to be infected, but the patient reported an allergy to methyl methacrylate (this allergy was not reported to the surgeon prior to implantation) in the simplex hv cement used.An i&d was performed and poly insert was revised.
Additional Manufacturer Narrative
Reported event: an event regarding patient factors (inflammation caused due to wound picking) involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection, material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were provided for review with 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, 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 additional information become available to indicate further evaluation is warranted, this record will be reopened.The following device were also listed in this report: device name#oem - simplex hv cement ; cat#unknown ; lot#unknown.It cannot be determined which, if any of these device may have caused or contributed to the patient's experience.Correction: d1.
Event or Problem Description
It was reported that the patient's left knee was revised due to inflammation and drainage.It did not appear to be infected, but the patient reported an allergy to methyl methacrylate (this allergy was not reported to the surgeon prior to implantation) in the simplex hv cement used.An i&d was performed and poly insert was revised.Update: rep provided additional information: patient had alleged an allergy to the cement used after the primary surgery.Allergy tests were negative.Surgeon reported that the patient was picking at the wound which led to inflammation and drainage and later, infection.

• Brand Name: X3 TRIATHLON INSERT CS NUM6 10MM
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18307815
• Report Number: 0002249697-2023-01538
• Device Sequence Number: 17838541
• Product Code: MBH
• UDI-Device Identifier: 07613327390575
• UDI-Public: 07613327390575
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173849
• 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,Followup
• Report Date (Section B): 03/27/2024
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 5531-G-610-E
• Device Lot Number: AL51D3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2023
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 107 KG