MAUDE Adverse Event Report: MAKO SURGICAL CORP. NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-609-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided. all (b)(4) products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.Additional information including pathology reports, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.   the following devices were also listed in this report: 5512-f-601 - tri ts femur sz6 left - gbr3v.5540-a-601 - triathlon femoral distal augment 5mm - size 6 left - ddz3t.5543-a-600 - tri post augment sz6 5mm - ger9u.5543-a-600 - tri post augment sz6 5mm - eu73a.5521-b-600 - tri ts baseplate size 6 - gid3ra.5549-a-341 - triathlon fem cone aug sz 4l - dnm6.5549-a-231 - triathlonasymconeaugsz c lm/r - ley7d.5560-s-212 - tri cemented stem 12mmx100mm - 0100580l.5560-s-212tri - cemented stem 12mmx100mm - 0101373l.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported the patient's left knee was revised due to infection.A poly swap with i&d was performed.Rep provided the primary and revision usage sheets and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 11869257
• Report Number: 0002249697-2021-00907
• Device Sequence Number: 19633872
• Product Code: MBH
• UDI-Device Identifier: 07613327288162
• UDI-Public: 07613327288162
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2021

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: 08/31/2024
• Device Model Number: 5537-G-609-E
• Device Catalogue Number: 5537-G-609-E
• Device Lot Number: 9J502D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 05/24/2021
• 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: 67 YR
• Patient Weight: 104