MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-616
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.The following devices were also listed in this report: triathlon prim bead pa sze6 bp; cat # 5526b600; lot # str3a.Triathlon femoral component; cat # unk_jr; lot # unknown.Uncoated tibial component; cat # unk_jr; lot # n8hxs.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Components revised due to wear and joint instability.Fracture of the posterolateral bearing surface was also noted.

• Brand Name: X3 TRIATHLON CS INSERT #6 16MM
• 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 NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16282696
• Report Number: 0002249697-2023-00106
• Device Sequence Number: 12458763
• Product Code: MBH
• UDI-Device Identifier: 07613327045987
• UDI-Public: 07613327045987
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2023

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: 11/30/2012
• Device Model Number: 5531-G-616
• Device Catalogue Number: 5531G616
• Device Lot Number: LAY240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2007
• 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 Sex: Unknown