MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Unspecified Infection (1930)
Date of Event	12/04/2020
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: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot and sterile lot.Conclusions: it was reported that the patient's knee was revised due to infection.The event could not be confirmed nor the exact cause be determined as the insufficient information was available.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.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
Septic arthritis, left knee.Arthrotomy, irrigation, and debridement and tibial polyethylene exchange for infected left total knee replacement.
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: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: event description: septic arthritis, left knee, arthrotomy, irrigation, and debridement and tibial polyethylene exchange for infected left total knee replacement.Implants involved: x3 triathlon cs insert #5 13mm materials reviewed: (b)(6) 2020: stryker pi report.(b)(6) 2020: h and px2: 71 yo man, 6 month left>right knee pain, cabinet maker, functional problems due to knee.Rom 0-1100, stable legs, plan tka (b)(6) 2020.(b)(6) 2020: intra-op recordx2, tka, 1 hour 20 min, primary oa, implants triathlon cs size 5, 13mm, s36 patella, cr femur size #5, size 5 baseplate, cemented.(b)(6) 2020: op note, oa left knee, sizes as above, im femur/em tibia, cemented.Confirmation: the primary knee was performed, but a revision surgery for infection cannot be confirmed without additional medical records.Root cause: a root cause cannot be determined device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot and sterile lot.Conclusions: it was reported that the patient's knee was revised due to infection.The event could not be confirmed nor the exact cause be determined as the insufficient information was available.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10-6 in accordance to applicable iso standards.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.Product surveillance will continue to monitor for trends.H3 other text: device not returned.
Event or Problem Description
Septic arthritis, left knee.Arthrotomy, irrigation, and debridement and tibial polyethylene exchange for infected left total knee replacement.

• Brand Name: X3 TRIATHLON CS INSERT #5 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: 11555617
• Report Number: 0002249697-2021-00514
• Device Sequence Number: 14436167
• Product Code: MBH
• UDI-Device Identifier: 07613327045888
• UDI-Public: 07613327045888
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 01/31/2024
• Device Model Number: 5531-G-513
• Device Catalogue Number: 5531G513
• Device Lot Number: LJA284
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 05/25/2021
• 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: 72 YR
• Patient Weight: 79