MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5532-G-411
Medical Device Problem Codes	Device-Device Incompatibility (2919); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured, and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported by sale rep that during knee surgery.Surgeon try to push tibia insert into tibia tray ,but tibia insert couldn't locked with tibia tray so that surgeon decided to change to the new one.The operation was completed successfully, and no surgical delayed.
Event or Problem Description
It was reported by sale rep that during knee surgery ,surgeon try to push tibia insert into tibia tray but tibia insert couldn't locked with tibia tray so that surgeon decided to change to the new one.The operation was completed successfully and no surgical delayed.
Additional Manufacturer Narrative
Reported event an event regarding seating/locking issues involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device noted the following: device had notable damage consistent with attempted implantation.No other remarkable observations were noted.Material analysis of the returned device noted, damage observed on the insert consistent with attempted implantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.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 has been no other similar events for the lot referenced.Conclusions: material analysis of the returned device noted the following: damage observed on the insert consistent with attempted implantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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: 10586993
• Report Number: 0002249697-2020-01994
• Device Sequence Number: 14197422
• Product Code: MBH
• UDI-Device Identifier: 07613327050714
• UDI-Public: 07613327050714
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 5532-G-411
• Device Catalogue Number: 5532-G-411
• Device Lot Number: 80081817D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 10/31/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 11/23/2020
• 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: Other