MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Model Number	5537-G-511
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event: an event regarding seating/locking issues involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: a medical review was not performed because no medical information was provided.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device and surgical notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
During a revision of patient's left knee, a 5x11 ts insert was implanted and removed because the locking mechanism was compromised.Rep reported there was no surgical delay.
Additional Manufacturer Narrative
Upon review, h1 was noted incorrect.This report is to correct h1.H3 other text : device not returned.
Event or Problem Description
During a revision of patient's left knee, a 5x11 ts insert was implanted and removed because the locking mechanism was compromised.Rep reported there was no surgical delay.

• Brand Name: NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7991655
• Report Number: 0002249697-2018-03461
• Device Sequence Number: 16564527
• Product Code: MBH
• UDI-Device Identifier: 07613327027297
• UDI-Public: 07613327027297
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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: No Information
• Device Expiration Date: 04/30/2023
• Device Model Number: 5537-G-511
• Device Catalogue Number: 5537-G-511
• Device Lot Number: W515M7
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 12/29/2020
• 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
• Patient Age: 80 YR