MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-611
Medical Device Problem Codes	Degraded (1153); Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, "patient needs patella component.When the surgeon opened the knee he could see that the posterior part of the insert had wear and was broken.".
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.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.H3 other text : not available.
Event or Problem Description
It was reported, "patient needs patella component.When the surgeon opened the knee he could see that the posterior part of the insert had wear and was broken.".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture and wear involving a triathlon insert was reported.The event was confirmed via evaluation of the returned device and clinician review of provided medical records.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the insert is worn.The damage present on the posterior portion was consistent with delamination and material loss.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.-clinician review: a review of the provided medical information by a clinical consultant indicated: "on 2/5/18 the patient underwent a pressfit tka performed.The patella was left unresurfaced.This verified vy the lateral view x-ray.On 3/24/23 the patient's knee was revised.During this surgery the patella was resurfaced with a pressfit tritanium patella.The tibial insert was also exchanged.Revision tka surgery with resurfacing of the patella and exchange of the tibial polyethylene insert is confirmed.The root cause of the need for patella resurfacing and liner exchange cannot be identified from this limited documentation." -product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient was revised and fracture/wear of the triathlon insert was identified.The fracture and wear of the insert were confirmed via evaluation of the returned device.A review of the provided medical records by a clinical consultant indicated: "on (b)(6) 2018 the patient underwent a pressfit tka performed.The patella was left unresurfaced.This verified vy the lateral view x-ray.On (b)(6) 2023 the patient's knee was revised.During this surgery the patella was resurfaced with a pressfit tritanium patella.The tibial insert was also exchanged.Revision tka surgery with resurfacing of the patella and exchange of the tibial polyethylene insert is confirmed.The root cause of the need for patella resurfacing and liner exchange cannot be identified from this limited documentation.".

• Brand Name: X3 TRIATHLON CS INSERT #6 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16797224
• Report Number: 0002249697-2023-00412
• Device Sequence Number: 3140330
• Product Code: MBH
• UDI-Device Identifier: 07613327045956
• UDI-Public: 07613327045956
• 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: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2023

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: 08/31/2022
• Device Model Number: 5531-G-611
• Device Catalogue Number: 5531G611
• Device Lot Number: LGC320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 102 KG