MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5532-G-609
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	01/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
There was a fracture of the tibial tray, damage to the polyethylene insert (some time after the original operation) and release of the elements into the joint.Revision surgery on (b)(6) 2023 was successfully completed.The insert was replaced with a new ps and the tibial tray was replaced with a revision ts no.7 along with 10 mm washers, 100/ 21 mm pin and 6 mm offset.Previously, the patient had also undergone bariatric surgery due to high body weight.
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon insert was reported.The event was confirmed via evaluation of the provided photographs of the devices.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.The provided photographs show that the insert has fractured into multiple pieces and a portion of the anterior edge of the baseplate has fractured off.-clinician review: a review of the provided medical information by a clinical consultant indicated: "the lateral view x-ray demonstrates a tibial insert locking wire displaced anteriorly indicative of damage to the tibial insert and possibly the tibial tray.The intra-operative photograph shows a ts polyethylene tibial insert that has significant wear and has fractured in to multiple pieces.I addition there is an intra-operative photograph showing a fractured tibial baseplate.Revision surgery for fracture of a tibial insert and baseplate is confirmed.No evidence was presented other than the pis to confirm previous lavage and liner exchange for prosthetic joint infection was provided.The root cause of the failure of the tibial tka insert cannot be established with the limited information provided." -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 fracture of the baseplate and insert.The reported device was not returned however photographs were provided for review.The provided photographs show that the insert has fractured into multiple pieces and a portion of the anterior edge of the baseplate has fractured off.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the devices, pathology reports, additional 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 or Problem Description
There was a fracture of the tibial tray, damage to the polyethylene insert (some time after the original operation) and release of the elements into the joint.Revision surgery on (b)(6) 2023 was successfully completed.The insert was replaced with a new ps and the tibial tray was replaced with a revision ts no.7 along with 10 mm washers, 100/ 21 mm pin and 6 mm offset.Previously, the patient had also undergone bariatric surgery due to high body weight.Update - the patient presented to the hospital at the beginning of (b)(6)2022 with discomfort of the knee joint , previously he had primary knee surgery on the triathlon primary system , some time later a knee lavage ( dero ) and pe insert replacement was performed due to symptoms of infection.Previously, the patient had also undergone bariatric surgery due to high body weight.After the patient reported in (b)(6)2022 and was referred for knee revision surgery.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 16240079
• Report Number: 0002249697-2023-00067
• Device Sequence Number: 6605530
• Product Code: MBH
• UDI-Device Identifier: 07613327050844
• UDI-Public: 07613327050844
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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 Model Number: 5532-G-609
• Device Catalogue Number: 5532-G-609
• 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: 01/05/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 05/24/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown