MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN RIGHT KNEE BASEPLATE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number UNK_JR

Device Problems Unstable (1667); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 11/01/2022

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.H3 other text : device not returned to the manufacturer.

Event Description

Patient reported revision due to pain, swelling and noted implant was "too big".Patient reported the baseplate was replaced but the femoral component was left in situ.

Manufacturer Narrative

Reported event: an event regarding incorrect selection and instability involving an unknown insert was reported.The event was not confirmed.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 records by a clinical consultant indicated: "this patient underwent a primary cementless cruciate retaining total knee arthroplasty in (b)(6) 2021.In (b)(6) 2021 the patient underwent a revision for pain, swelling and instability with the tibial component being oversized.The tibial component was replaced and a thicker polyethylene was utilized.I can confirm that the primary and revision procedure took place since i was able to review the operation reports.I have no x-rays so i cannot determine whether the tibial component was indeed oversized or not.The root cause of these events cannot be determined with absolute certainty.The causes of early revision for pain swelling and instability are multifactorial but almost always involves surgical technique, especially in the choice of implants, positioning and kinematic restoration and ligament balance.Remotely, patient factors can contribute including activity level and bmi and whether or not trauma occurred.In this case no trauma was noted.I would not assign any causality to the implant itself.However the explanted prostheses should be submitted to stryker for evaluation and examination.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 pain, swelling and noted implant was "too big".A review of the provided medical records by a clinical consultant indicated: "this patient underwent a primary cementless cruciate retaining total knee arthroplasty in (b)(6) 2021.In (b)(6) 2021 the patient underwent a revision for pain, swelling and instability with the tibial component being oversized.The tibial component was replaced and a thicker polyethylene was utilized.I can confirm that the primary and revision procedure took place since i was able to review the operation reports.The root cause of these events cannot be determined with absolute certainty.The causes of early revision for pain swelling and instability are multifactorial but almost always involves surgical technique, especially in the choice of implants, positioning and kinematic restoration and ligament balance.Remotely, patient factors can contribute including activity level and bmi and whether or not trauma occurred.In this case no trauma was noted.I would not assign any causality to the implant itself.However the explanted prostheses should be submitted to stryker for evaluation and examination.The exact cause of the event could not be determined because insufficient information was provided.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient reported revision due to pain, swelling and noted implant was "too big".Patient reported the baseplate was replaced but the femoral component was left in situ.

• Brand Name: UNKNOWN RIGHT KNEE BASEPLATE
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17494355
• MDR Text Key: 320754049
• Report Number: 0002249697-2023-00885
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 93 KG