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	Aspiration/Inhalation (1725); Pain (1994)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding patient factors involving a triathlon insert was reported, the event was not confirmed.Method & results: device evaluation and results: not performed as product remains implanted.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: re pi which represents a female patient.The event description states: ".Surgeon reported.High complication rate in patients whose primary procedure were mako.Includes effusion, pain, stiffness, possibly requiring scopes and/or poly exchanges." this is the 1st of 10 cases.(b)(6) 2019 implant labels: triathlon #3 left cr femur, #3 primary tibial baseplate, #3/9 x3 cs insert, 29/9 x3 asymmetric patella typed case history: injury left knee (b)(6) 2015, arthroscopy with no relief, 06/17/19 left mako tka "no complications." post-operative course persistent pain and swelling, 7 months post-op aspirated left knee 10 ml "bloody clear fluid", 1 year post-op persistent pain "x-ray appears normal" 13 months post-op aspirated 15 ml bloody fluid and injected celestone.No imaging studies, no operative reports, no laboratory reports.Based upon the information supplied, no correlation between the symptoms described and the mako procedure or instruments can be made, and creation of a medical report is not possible for this case.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been one other similar event for the reported lot.Conclusion: the surgeon reported a high complication rate in patients whose primary procedure were mako.Includes effusion, pain, stiffness, possibly requiring scopes and/or poly exchanges.A review of the provided medical records by a clinician indicated that: based upon the information supplied, no correlation between the symptoms described and the mako procedure or instruments can be made, and creation of a medical report is not possible for this case further information such as imaging studies, operative reports and laboratory reports are required to fully investigate the event.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Addition devices: catalog numbers and lot codes of other devices listed in this report: 5510f201;triathlon cr fem comp # 2 l-cem;enp9n.5551-g-299;triathlon asymettric x3 patella;hrk5.5520b200;triathlon prim cem fxd bplt #2;exp9n.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
This pi is for patient 3 of 10.Surgeon reported he is experiencing a high complication rate with patients whose primary procedures were mako procedures.The nature of the 10 cases is unknown at the time of report.Complications reported include effusions, pain, stiffness, possibly requiring 'scopes' and/ or poly exchanges.The nature of intervention for each of the 10 patients is unknown.Update 01/september/2020: as reported by clinician review, patient had an arthroscopic debridement of adhesions of her left knee on (b)(6) 2020.

• 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: 10681107
• Report Number: 0002249697-2020-02134
• Device Sequence Number: 3000107
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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: 02/28/2024
• 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: 09/15/2020
• Initial Report FDA Received Date: 10/14/2020
• 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: 66 YR
• Patient Weight: 68