MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #4 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5510-F-401

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2023

Event Type  Injury  

Event Description

Pt is inquiring if product is subject to recall.Pt stated that a left triathlon femoral component is implanted in her right knee.Pending revision, date tbd.Primary surgery (b)(6) 2018.

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.Device remains implanted.

Event Description

Pt is inquiring if product is subject to recall.Pt stated that a left triathlon femoral component is implanted in her right knee.Pending revision, date tbd.Primary surgery november 2018.

Manufacturer Narrative

Reported event: an event regarding incorrect selection involving a triathlon femoral component was reported.The event was confirmed through medical review.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: narrative: no medical history was provided for review.The inquiry was whether the implant was recalled, a claim that there was incorrect sided implant implanted and there was an anticipated revision surgery.The operative notes were for a right total knee.The implant stickers show a left femoral component.The unlabeled x-ray appears to show a left femoral component in a right knee.A bone scan does show some uptake at the tibia and patellar interface.No other history was provided for review.Conclusion/assessment: a patient was inquiring as to a recall of implants and stated a left femur was put into the right side.A revision surgery is pending without a date defined.No medical history other than the operative note was provided for review.There was some increased uptake on a bone scan but no reading attached and it was undated.More importantly, the x-rays show what appears to be a left femur in a right knee.This was confirmed by the implant stickers.Event confirmation: a recall cannot be confirmed.A left femur in a right knee can be confirmed.Root cause: the root cause for the proposed revision cannot be determined without additional medical information.No recall has been defined.The likely cause of the patient¿s dissatisfaction and proposed revision was likely implantation of a left femoral component into a right knee.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: pt stated that a left triathlon femoral component is implanted in her right knee.As per the medical review :the operative notes were for a right total knee.The implant stickers show a left femoral component.The unlabeled x-ray appears to show a left femoral component in a right knee.It is likely that the issue is the result of user error as no manufacturing-related product problem was found given the information provided.Pt is inquiring if product is subject to recall.No devices associated with this event were involved in a recall.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON CR FEM COMP #4 L-CEM
• Type of Device: 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: 16662743
• MDR Text Key: 312499777
• Report Number: 0002249697-2023-00348
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327040272
• UDI-Public: 07613327040272
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 5510-F-401
• Device Catalogue Number: 5510F401
• Device Lot Number: DPN2L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 05/26/2023
• Supplement Dates FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 78 KG