MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 19MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-619-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: tri ts femur sz5 left; 5512-f-501 ;daz3i; tri ts baseplate size 6; 5521-b-600 ; edx4ga; tri press-fit stem 19mm x 100mm; 5565-s-019; 0066214m; triathlon femoral distal augment 5mm - size 5 left; 5540-a-501; evl7u; triathlonasymconeaugsz d lm/rl; 5549-a-241; ay5h; tri post augment sz5 5mm; 5543-a-500; eug3z; tri press-fit stem 18mm x 100mm; 5565-s-018; 0102684k; triathlon femoral distal augment 5mm - size 5 left; 5540-a-501; byv7h; tri post augment sz5 5mm; 5543-a-500; e3z4e.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: 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 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.
Event or Problem Description
It was reported that the patient's left knee was revised due to infection.A femoral component, insert, and tibial baseplate were removed and a cement spacer with 2 stems added were implanted.Rep reported he may be able to obtain the usage sheet from the prior procedure, and otherwise confirmed that no further information will be released by the hospital or surgeon.Update 23/february/2021 wg: rep provided the usage sheet from the previous procedure.5 augments and 2 stems were also revised.

• Brand Name: NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 19MM
• 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: 11509663
• Report Number: 0002249697-2021-00481
• Device Sequence Number: 2776382
• Product Code: MBH
• UDI-Device Identifier: 07613327288278
• UDI-Public: 07613327288278
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2021

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: 09/22/2024
• Device Model Number: 5537-G-619-E
• Device Catalogue Number: 5537-G-619-E
• Device Lot Number: KX81T0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/17/2021
• 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: 75 YR