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

Model Number	5530-G-411
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation 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.
Event or Problem Description
Insert changed due to instability.
Additional Manufacturer Narrative
Reported event; an event regarding instability involving a triathlon insert was reported.The event was confirmed based on medical review.Method & results: device evaluation and results: visual inspection: visual inspection was performed as part of the material evaluation and indicated the following comments: examination by material analysis engineer indicated burnishing, scratching and third body indentation were observed on the insert.These are common damage modes of uhmwpe.Explantation damage was also observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment:(b)(6) 2011 op note in swedish: right tka - triathlon #4 pa tibial baseplate, #4 right pa cr femur, #4/11 x3 cr insert.Brief translation: ".No periop complication, stable knee, full mobility." (b)(60 2020 op note in swedish: "implants: #4/13 cs insert, 32 metal backed asym.Pat." brief translation: ".Minimal plastic fracture post medial which can hardly explain patient symptoms.Replace the patella.No periop complication." (b)(6) 2020 x-rays: ap, lateral, patellar views right knee: uncemented right tka with no patellar resurfacing, anterior subluxation of tibial component noted on lateral, components well fixed and positioned.No clinical or pmh, no dated serial x-rays, no examination of explanted components.While the lateral x-ray appears to confirm the event description of "instability", insufficient information is available to create a medical report for this case.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 reported lot.Conclusion: it was reported that insert changed due to instability.The event was confirmed based on medical review.A review of the provided medical records by a clinical consultant stated the following comment:11/30/11 op note in swedish: right tka - triathlon #4 pa tibial baseplate, #4 right pa cr femur, #4/11 x3 cr insert.Brief translation: ".No periop complication, stable knee, full mobility." (b)(6) 2020 op note in swedish: "implants: #4/13 cs insert, 32 metal backed asym.Pat." brief translation: ".Minimal plastic fracture post medial which can hardly explain patient symptoms.Replace the patella.No periop complication." (b)(6) 2020 x-rays: ap, lateral, patellar views right knee: uncemented right tka with no patellar resurfacing, anterior subluxation of tibial component noted on lateral, components well fixed and positioned.No clinical or pmh, no dated serial x-rays, no examination of explanted components.While the lateral x-ray appears to confirm the event description of "instability", insufficient information is available to create a medical report for this case.The exact cause of the event could not be determined because insufficient information was provided.Additional information are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.
Event or Problem Description
Insert changed due to instability.

• Brand Name: TRIATHLON CR 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: 11590089
• Report Number: 0002249697-2021-00560
• Device Sequence Number: 17338577
• Product Code: MBH
• UDI-Device Identifier: 07613327050486
• UDI-Public: 07613327050486
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 02/28/2016
• Device Model Number: 5530-G-411
• Device Catalogue Number: 5530-G-411
• Device Lot Number: MKANWK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 08/17/2021
• 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: 63 YR
• Patient Weight: 90