MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON ASYMMETRIC X3 PATELLA; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5551-G-350-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient came in due to pain in right knee.Started superolaterally and inferolaterally around the patella.Also intermittent swelling.Aspirated showing wcc 14900.No organisms.Possibly viral vs non-specific inflammation in aetiology.No implants were removed.
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.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.The following devices were also listed in this report: x3 triathlon cs insert #6 11mm; cat#5531-g-611-e ; lot#lkf475.Triathlon cr fem comp #7 r-cem; cat#5510f702 ; lot#l297n.Tri ts baseplate size 6; cat#5521-b-600 ; lot#h4u9ra.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned to the manufacturer.

• Brand Name: TRIATHLON ASYMMETRIC X3 PATELLA
• 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: 14920884
• Report Number: 0002249697-2022-00968
• Device Sequence Number: 6204029
• Product Code: MBH
• UDI-Device Identifier: 07613327314793
• UDI-Public: 07613327314793
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/05/2022

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: 03/31/2026
• Device Model Number: 5551-G-350-E
• Device Catalogue Number: 5551-G-350-E
• Device Lot Number: M3M9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• 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: Other
• Patient Sex: Unknown