MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-LIMERICK X3 TRIATHLON CS INSERT #2 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-209
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, 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 reported discrepancies.There has been one other event for the lot referenced but it is the same patient and same device.Catalog numbers and lot codes of other devices listed in this report: triathlon prim cem fxd bplt #2; 5520b200; exp9n.Triathlon asymmetric x3 patella; 5551-g-299; hrk5.Triathlon cr fem comp #2 l-cem; 5510f201; epy9a.3.0 rio® robotic arm - mics; 209999; rob406.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not available.
Event or Problem Description
Clinician review of additional information received for indicates patient had a left knee manipulation due to pain and swelling on (b)(6) 2019.

• Brand Name: X3 TRIATHLON CS INSERT #2 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• MDR Report Key: 10585034
• Report Number: 0002249697-2020-01984
• Device Sequence Number: 2822841
• Product Code: MBH
• UDI-Device Identifier: 07613327045659
• UDI-Public: 07613327045659
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

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: 02/01/2024
• Device Model Number: 5531-G-209
• Device Catalogue Number: 5531G209
• Device Lot Number: LJB431
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 68