MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 2; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5521-B-200

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Injury (2348); Inadequate Osseointegration (2646)

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.Device not returned.

Event Description

Medical records provided have indicated additional treatments/revisions the patient underwent.This pi is for a third revision surgery the patient underwent on 29 may 2018 due to loosening on tibial side (baseplate/tibial stem/augment) loosening.An intraoperative fracture of the tibia was also reported to have occurred during this revision surgery on (b)(6) 2019.Excerpt from medical review: "early loosening of baseplate with stem extender and augment occurred requiring a third revision surgery." "removing all bone cement from the tibial canal was again difficult and required making a window in the tibial cortical bone for distal access to the bone cement for removal.Lateral and posterior ¿cracks¿ developed in the tibial cortex during these difficult manoeuvres to remove all bone cement.".

Manufacturer Narrative

An event regarding loosening and intraoperative fracture involving a triathlon baseplate was reported and confirmed through a medical review for this patient.Method & results: device evaluation and results: not performed as product was not returned clinician review: a review of the provided medical records by a clinical consultant indicated: the use of a still relatively short 100-mm stem extender below a large augment in a proximal tibial bone defect condition did not provide adequate stability to the newly implanted baseplate during the previous revision with excessive micromotion in the implant bone interface resulting in early loosening requiring a third revision within short interval.A strong clinical suspicion for presence of a lowgrade infection in the implant-bone interface, although not explicitly proven, may have accelerated the baseplate fixation failure.Excess bone removal as required for removal of well-fixed cemented pkr baseplate during the first revision of (b)(6) 2016.Removing all bone cement from the tibial canal was again difficult and required making a window in the tibial cortical bone for distal access to the bone cement for removal.Lateral and posterior ¿cracks¿ developed in the tibial cortex during these difficult manoeuvres to remove all bone cement device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: a review of the provided medical records by a clinical consultant indicated: the use of a still relatively short 100-mm stem extender below a large augment in a proximal tibial bone defect condition did not provide adequate stability to the newly implanted baseplate during the previous revision with excessive micromotion in the implant bone interface resulting in early loosening requiring a third revision within short interval.A strong clinical suspicion for presence of a lowgrade infection in the implant-bone interface, although not explicitly proven, may have accelerated the baseplate fixation failure.Excess bone removal as required for removal of well-fixed cemented pkr baseplate during the first revision of (b)(6) 2016.Removing all bone cement from the tibial canal was again difficult and required making a window in the tibial cortical bone for distal access to the bone cement for removal.Lateral and posterior ¿cracks¿ developed in the tibial cortex during these difficult manoeuvres to remove all bone cement.

Event Description

Medical records provided have indicated additional treatments/revisions the patient underwent.This pi is for a third revision surgery the patient underwent on (b)(6) 2018 due to loosening on tibial side (baseplate/tibial stem/augment) loosening.An intraoperative fracture of the tibia was also reported to have occurred during this revision surgery on (b)(6) 2019.Excerpt from medical review: "early loosening of baseplate with stem extender and augment occurred requiring a third revision surgery." "removing all bone cement from the tibial canal was again difficult and required making a window in the tibial cortical bone for distal access to the bone cement for removal.Lateral and posterior ¿cracks¿ developed in the tibial cortex during these difficult manoeuvres to remove all bone cement.".

• Brand Name: TRI TS BASEPLATE SIZE 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
• MDR Report Key: 9329141
• MDR Text Key: 168016398
• Report Number: 0002249697-2019-03778
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327026306
• UDI-Public: 07613327026306
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

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 Catalogue Number: 5521-B-200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR