MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SERIES 7000 STANDARD TIBIA; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 7115-0005

Device Problems Degraded (1153); Osseointegration Problem (3003); Migration (4003)

Patient Problems Arthritis (1723); Insufficient Information (4580)

Event Date 05/12/2022

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.

Event Description

Aseptic mobilization of the prosthesis.Reason the device was used: right knee osteoarthritis.Total right knee replacement.Year of implant: 2017.

Manufacturer Narrative

Reported event: an event regarding wear and loosening involving a scorpio baseplate was reported.Wear was confirmed via evaluation of the provided photographs of the device.Loosening was not confirmed.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the device indicated that the device has a small area of wear on the inner side of the posterior edge.The device exhibits residue and minor scratches consistent with explantation.-clinician review: a review of the provided medical information by a clinical consultant indicated: "this patient underwent a cemented scorpio total knee arthroplasty in 2017.According to the summary the implant was removed on (b)(6), 2022 for "aseptic loosening of the prosthesis." i cannot confirm that revision occurred since i have no supporting evidence to document this such as office notes, an operation note or post revision x-rays.I also cannot confirm that aseptic loosening of the prosthesis occurred.The x-rays provided, in my opinion show that the patient has gross instability of the implant.I see no evidence of loosening of either the femoral or tibial component but, granted, only two x-rays are provided.The causes of late instability of a cemented total knee arthroplasty are multifactorial including surgical technique, patient factors including bmi and activity level.It would be unusual to implicate implant factors as a cause of instability." -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 aseptic loosening.The reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the device indicated that the device has a small area of wear on the inner side of the posterior edge.The device exhibits residue and minor scratches consistent with explantation.A review of the provided medical information by a clinical consultant indicated: "this patient underwent a cemented scorpio total knee arthroplasty in 2017.According to the summary the implant was removed on (b)(6), 2022 for "aseptic loosening of the prosthesis." i cannot confirm that revision occurred since i have no supporting evidence to document this such as office notes, an operation note or post revision x-rays.I also cannot confirm that aseptic loosening of the prosthesis occurred.The x-rays provided, in my opinion show that the patient has gross instability of the implant.I see no evidence of loosening of either the femoral or tibial component but, granted, only two x-rays are provided.The causes of late instability of a cemented total knee arthroplasty are multifactorial including surgical technique, patient factors including bmi and activity level.It would be unusual to implicate implant factors as a cause of instability." 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

Aseptic loosening of the prosthesis.Reason the device was used: right knee osteoarthritis.Total right knee replacement.Year of implant: 2017.Update per med review: "there is rather profound anterior subluxation of the tibia on femur indicating gross instability.".

• Brand Name: SERIES 7000 STANDARD TIBIA
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14634108
• MDR Text Key: 293566509
• Report Number: 0002249697-2022-00809
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07613327033342
• UDI-Public: 07613327033342
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K910990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 7115-0005
• Device Catalogue Number: 7115-0005
• Device Lot Number: D47KJXA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2016
• 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