MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-516
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: tri ts femur sz4 left, 5512-f-401, blt9y.Triathlon femoral distal augment 10mm - size 4 left, 5541-a-401, abx3s.Triathlon femoral distal augment 10mm - size 4 left, 5541-a-401, abx3s.Tri post augment sz4 5mm, 5543-a-400, axr3l.Tri post augment sz4 5mm, 5543-a-400, bdv7t.Tri cemented stem 12mmx100mm, 5560-s-212, 0062845h.Tri cemented stem 12mmx100mm, 5560-s-212, 0041497e.Tri ts baseplate size 5; 5521-b-500; btv9sa.Tri rm/ll tib aug sz5 5mm; 5545-a-502, erenl3a.Tri lm/rl tib aug sz5 10mm, 5546-a-501, erewp5d.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: all stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.  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.   no further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's left knee was revised due to infection.A femoral component with 4 augments and stem (implanted (b)(6) 2018) and insert (implanted (b)(6) 2019, reported in pi (b)(4)) were revised.Rep provided revision usage sheet and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM
• 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: 11340294
• Report Number: 0002249697-2021-00289
• Device Sequence Number: 823371
• Product Code: MBH
• UDI-Device Identifier: 07613327027327
• UDI-Public: 07613327027327
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2021

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: 08/23/2023
• Device Model Number: 5537-G-516
• Device Catalogue Number: 5537-G-516
• Device Lot Number: 8V0L36
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2021
• Initial Report FDA Received Date: 02/17/2021
• 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: 69 YR
• Patient Weight: 73