MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #4R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5517-F-402
Medical Device Problem Codes	Malposition of Device (2616); Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "revision of right femur." a femoral component and insert were revised.Update (b)(6) 2022: the revised that was on (b)(6) 2022.The first surgery was done about month and half before.Femoral component was removed due to its mal-placement.Pt complaining of pain.
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.The following devices were also listed in this report: x3 triathlon cs ins size 4 9mm; cat # 5531g409; lot # unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Additional Manufacturer Narrative
Implant date updated.Reported event: an event regarding malposition involving a triathlon femoral component was reported.The event was not confirmed.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: "an ap and lateral view of a right knee is provided.It appears to be a cementless cruciate retaining triathlon tritanium total knee arthroplasty.From the x-rays provided i do not see any gross ¿malplacement.¿ lateral view shows the femoral component obliquely.[¿] as mentioned, it is difficult to implicate a device or procedure based on the facts, i have been given but theoretically if the revision was done for "malplacement," approximately a month and a half after the index surgery, then unless there was trauma, the cause would be iatrogenic with improper or inaccurate assessment of bony landmarks, alignment, and position.The implants themselves cannot be implicated.As for the root cause of "malplacement," it is almost always operative technique in nature with inaccurate assessment of bony landmarks, position, and alignment.No patient related or implant factors are implicated." -product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to malposition of the femoral component.A review of the provided medical information by a clinical consultant indicated: "an ap and lateral view of a right knee is provided.It appears to be a cementless cruciate retaining triathlon tritanium total knee arthroplasty.From the x-rays provided i do not see any gross ¿malplacement.¿ lateral view shows the femoral component obliquely.[¿] as mentioned, it is difficult to implicate a device or procedure based on the facts, i have been given but theoretically if the revision was done for "malplacement," approximately a month and a half after the index surgery, then unless there was trauma, the cause would be iatrogenic with improper or inaccurate assessment of bony landmarks, alignment, and position.The implants themselves cannot be implicated.As for the root cause of "malplacement," it is almost always operative technique in nature with inaccurate assessment of bony landmarks, position, and alignment.No patient related or implant factors are implicated." 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.
Event or Problem Description
As reported: "revision of right femur." a femoral component and insert were revised.Update 4/20/2022: the revised that was (b)(6) 2022.The first surgery was done about month and half before.Femoral component was removed due to its mal-placement.Pt complaining of pain.

• Brand Name: TRIATHLON P/A CR BEADED #4R
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14237692
• Report Number: 0002249697-2022-00629
• Device Sequence Number: 17365198
• Product Code: MBH
• UDI-Device Identifier: 07613327040944
• UDI-Public: 07613327040944
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2022

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 Model Number: 5517-F-402
• Device Catalogue Number: 5517F402
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 66 YR
• Patient Sex: Female