MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 25MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-525
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/08/2019
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: product evaluation and results: not performed as the device was not returned.Medical records received and evaluation: the review of the provided medical records states the following: "rejected for medical review - cannot confirm event, need additional serial post op x-rays and revision operative report." product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there were no other events for the lot and sterile lot provided.Conclusions: the review of the provided medical records states the following: "rejected for medical review cannot confirm event, need additional serial post op x-rays and revision operative report." the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, additional serial post-operative x-rays and the revision operative report as well as follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: tri ts femur sz6 left; cat#5512-f-601; lot#mzkx; tri ts baseplate size 5; cat#5521-b-500; lot#myku; tri press-fit stem 19x150mm; cat#5566-s-019; lot#m9c55i; tri press-fit stem 15x150mm; cat#5566-s-015; lot#m9h61i; triathlon femoral distal augment 10mm - size 6 left; cat#5541-a-601; lot#kodz; triathlon femoral distal augment 10mm - size 6 left; cat#5541-a-601; lot#kodz; triathlon total knee system offset adapter 4mm; cat#5570-s-040; lot#m9t69h; tri post augment sz6 5mm; cat#5543-a-600; lot#kylw; tri post augment sz6 10mm; cat#5544-a-600; lot#mgby; triathlon total knee system offset adapter 8mm; cat#5570-s-080; lot#m7c39ad.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Not returned.
Event or Problem Description
It was reported that the patient's left knee was revised.As reported by rep: "revision of a revision on (b)(6) 2015 [revision was of competitor devices]¿due to potential infection".A 5x25 ts insert was revised to a 5x31 ts insert.

• Brand Name: NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 25MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8399934
• Report Number: 0002249697-2019-01270
• Device Sequence Number: 13531250
• Product Code: MBH
• UDI-Device Identifier: 07613327027365
• UDI-Public: 07613327027365
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2019

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: 05/31/2017
• Device Catalogue Number: 5537-G-525
• Device Lot Number: MLJVWE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 03/07/2019
• 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: 68 YR
• Patient Weight: 91