MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-411
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fibrosis (3167)
Date of Event	01/04/2022
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.Device not returned.
Event or Problem Description
It has been reported "this patient had functional loss due to arthrofibrosis 8 weeks postoperatively.At (b)(6) 2022 the patient was hospitalized to perform manipulation under anesthesia." update - no explant or revision surgeries were done or planned.
Event or Problem Description
It has been reported "this patient had functional loss due to arthrofibrosis 8 weeks postoperatively.At (b)(6) 2022 the patient was hospitalized to perform manipulation under anesthesia." update - no explant or revision surgeries were done or planned.
Additional Manufacturer Narrative
The following devices were also listed in this report: tritanium bplate triathlon s4; cat# 5536b400; lot# ctd48544 triathlon p/a cr beaded #3r; cat# 5517f302; lot# ld47d it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding rom 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 remains implanted.-clinician review: a review of the provided medical information by a clinical consultant indicated: "the x-rays show a press fit tka in anatomic position and alignment with pristine bone prosthetic interfaces.The implant record indicates a tka was performed.It is confirmed that a tka was performed.No information was available to confirm or refute the development of arthrofibrosis was presented.No root cause can be determined for this event." -product history review: review of the device history records indicate the devices were manufactured and accepted into final stock on december 10, 2020 with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was hospitalized to perform manipulation under anesthesia due to arthrofibrosis.A review of the provided medical information by a clinical consultant indicated: "the x-rays show a press fit tka in anatomic position and alignment with pristine bone prosthetic interfaces.The implant record indicates a tka was performed.It is confirmed that a tka was performed.No information was available to confirm or refute the development of arthrofibrosis was presented.No root cause can be determined for this event." the exact cause of the event could not be determined because insufficient information was provided.Further information such as the primary operative report and manipulation under anesthesia 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: X3 TRIATHLON CS INS SIZE4 11MM
• 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 NJ NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; centennial park, elstree; limerick WD6 3-SJ ; EI WD6 3SJ ; 61498200
• MDR Report Key: 13541402
• Report Number: 0002249697-2022-00240
• Device Sequence Number: 4299275
• Product Code: MBH
• UDI-Device Identifier: 07613327045789
• UDI-Public: 07613327045789
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2022

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: 11/30/2025
• Device Model Number: 5531-G-411
• Device Catalogue Number: 5531G411
• Device Lot Number: LKL261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 68 KG