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

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 09/17/2019

Event Type  Injury  

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 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
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: daniela davila ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 10585034
• MDR Text Key: 208512363
• Report Number: 0002249697-2020-01984
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327045659
• UDI-Public: 07613327045659
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 68