MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #5R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5517F502
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Inadequate Osseointegration (2646)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right knee was revised.As reported: "patient was revised due to loose femur.No other information available due to hospital policy." a cr femoral component and insert were revised to a ts femoral component with stem and augments, and a new insert.Mako robot was used in the revision for bone cuts.Rep confirmed there are no allegations against the revised insert.Update 01-sep-2023 mf: per clinician review of the provided medical records, the x-rays show "a displaced fracture of the medial femoral condyle.".
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture and loosening involving a triathlon femoral component was reported.Periprosthetic fracture was confirmed via clinician review of the provided medical records.Loosening was not confirmed from the information provided.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: "both ap x-rays show a pressfit tka in anatomic position.I both x-rays there appears to be a displaced fracture of the medial femoral condyle.By virtue of x-rays showing a displaced fracture of the medial femoral condyle instability is confirmed.The implant for a ts revision knee confirms the revision surgery.The root cause of medial femoral condyle cannot be determined from the limited documentation provided." 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 due to loosening of the femoral component.A review of the provided medical information by a clinical consultant indicated: "both ap x-rays show a pressfit tka in anatomic position.I both x-rays there appears to be a displaced fracture of the medial femoral condyle.By virtue of x-rays showing a displaced fracture of the medial femoral condyle instability is confirmed.The implant for a ts revision knee confirms the revision surgery.The root cause of medial femoral condyle cannot be determined from the limited documentation provided." the reported loosening event was not confirmed from the information provided.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.

• Brand Name: TRIATHLON P/A CR BEADED #5R
• 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: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17735300
• Report Number: 0002249697-2023-01031
• Device Sequence Number: 5472529
• Product Code: MBH
• UDI-Device Identifier: 07613327040968
• UDI-Public: 07613327040968
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K051380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2023

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: 12/31/2022
• Device Catalogue Number: 5517F502
• Device Lot Number: RHJ4C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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: 68 YR
• Patient Sex: Male