MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #2; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5520-B-200

Device Problem Migration (4003)

Patient Problem Ambulation Difficulties (2544)

Event Date 07/27/2022

Event Type  Injury  

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.

Event Description

It was reported the patient's left knee was revised due to subsidence of the tibial baseplate.The baseplate was revised.The femoral component was revised both to convert the knee to a ts, and to gain access to the baseplate.Intra-operatively, significant wear of the insert was noted.

Manufacturer Narrative

Reported event an event regarding subsidence involving a triathlon baseplate was reported.The event was confirmed via medical review.Method & results -product evaluation and results: the reported device was not returned however photographs were provided for review.The photos show a cleaned explanted baseplate.Bone cement was observed on it.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: i had the opportunity to review documentation related to product inquiry summary and an operative report, an ap x-ray of a pressfit ps tka, a photograph of the explanted tibial liner, and a photograph of the explanted baseplate and femur.The ap x-ray demonstrates considerable tibial baseplate subsidence in to varus positioning.The photograph of the explanted tibial insert shows significant pitting and delamination of the weight bearing surface.The photographs of the explanted femur and tibia show no obvious defects.It is confirmed that a pressfit tka had been performed and that the tibial component subsided into a varus position.It is further confirmed that the knee was revised as evidenced by photographs of the explanted components.The root cause of the subsidence and tka failure cannot be determined from this limited documentation.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant stated the following comment: i had the opportunity to review documentation related to product inquiry summary and an operative report, an ap x-ray of a pressfit ps tka, a photograph of the explanted tibial liner, and a photograph of the explanted baseplate and femur.The ap x-ray demonstrates considerable tibial baseplate subsidence in to varus positioning.The photograph of the explanted tibial insert shows significant pitting and delamination of the weight bearing surface.The photographs of the explanted femur and tibia show no obvious defects.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.Correction: manufacturing site for devices - lim.

Event Description

It was reported the patient's left knee was revised due to subsidence of the tibial baseplate.The baseplate was revised.The femoral component was revised both to convert the knee to a ts, and to gain access to the baseplate.Intra-operatively, significant wear of the insert was noted.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #2
• 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 NJ NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15274920
• MDR Text Key: 298387771
• Report Number: 0002249697-2022-01216
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041569
• UDI-Public: 07613327041569
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2010
• Device Model Number: 5520-B-200
• Device Catalogue Number: 5520B200
• Device Lot Number: SABNF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2005
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 76 KG