MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #6 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5510-F-602

Device Problem Unstable (1667)

Patient Problems Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 12/05/2022

Event Type  Injury  

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.The following devices were also listed in this report: x3 triathlon cs insert #6 9mm; cat #: 5531-g-609-e; lot #: tw3xln.Simplex hv with gentamicin us 1 pack; cat #: 6195-1-001; lot #: 121bb837bc.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

It was reported that the patient's right knee was revised due to swelling, clanking, and joint laxity.A cr cemented femur and cs insert were revised to ps implants.Rep confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

An event regarding instability involving a triathlon femoral component was reported.The event was confirmed via clinician review of the provided medical records.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: "the patient had a right tka in feb of 2022.Over the next 5 months he developed increasing problems with the knee.Swelling, laxity and clicking/clunking.His exam was consistent with instability and the resultant swelling and synovitis.An aspiration did not show signs of infection and relieved some of the discomfort.The swelling returned and the instability persisted.A decision was made to perform a revision surgery with either a thicker polyethylene or revision to a ps or ts style implant.The patient had planned for surgery but prior to surgery was considering a repeat aspiration to improve the symptoms for a vacation.The surgical notes, preoperative, postoperative care notes, notes related to revision surgery, and radiographs were not provided for review.Conclusion/assessment: right knee revision surgery proposed (performed by complaint report only) for knee instability, pain and swelling.Event confirmation: the revision cannot be confirmed.The patient¿s complaints of instability and swelling were confirmed in office notes.Root cause: a root cause cannot be ascertained without additional records.The event itself was not confirmed." -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 joint instability.The event was confirmed via clinician review of the provided medical records.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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 Description

It was reported that the patient's right knee was revised due to swelling, clanking, and joint laxity.A cr cemented femur and cs insert were revised to ps implants.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRIATHLON CR FEM COMP #6 R-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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16021895
• MDR Text Key: 305877278
• Report Number: 0002249697-2022-01867
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327040326
• UDI-Public: 07613327040326
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5510-F-602
• Device Catalogue Number: 5510F602
• Device Lot Number: N647T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 88 KG