MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-513-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: tri ts femur sz5 left; cat # 5512-f-501; lot # exv7g; triathlon femoral distal augment 10mm - size 5 left; cat # 5541-a-501; lot # dil3z; triathlon femoral distal augment 10mm - size 5 left; cat # 5541-a-501; lot # ebr7r; triathlon cemented stem-15mm x 50mm; cat # 5560-s-115; lot # dzy7e; tri post augment sz5 5mm; cat # 5543-a-500; lot # el37u; triathlon cemented stem-15mm x 50mm; cat # 5560-s-115; lot # 0109148e; triathlon asymmetric x3 patella; cat # 5551-g-320-e; lot # m5kt; tri ts baseplate size 5; cat # 5521-b-500; lot # gvd7oa; tri cemented stem 12mmx50mm; cat # 5560-s-112; lot # 0105589j; tri rm/ll tib aug sz5 10mm; cat # 5546-a-502; lot # erfcz1a; tri lm/rl tib aug sz5 10mm; cat # 5546-a-501; lot # erffe5a; triathlon stem extender 25mm; cat # 5571-s-025; lot # 1l537h.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.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 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 stryker 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.Not available.
Event or Problem Description
It was reported that the patient's left knee was revised due to acute infection.A washout with a liner exchange was performed.Rep provided a usage sheet from a previous stage 2 revision (stage 1 revision reported) and may be able to provide revision usage, otherwise confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM
• 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: 11451736
• Report Number: 0002249697-2021-00412
• Device Sequence Number: 19696938
• Product Code: MBH
• UDI-Device Identifier: 07613327287813
• UDI-Public: 07613327287813
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2021

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: 06/30/2024
• Device Model Number: 5537-G-513-E
• Device Catalogue Number: 5537-G-513-E
• Device Lot Number: 1V6P5P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2021
• Initial Report FDA Received Date: 03/10/2021
• 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: 68 YR