MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ R; KNEE FEMUR CEMENTED

Model Number 02.12.0025R

Device Problem Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/23/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 24 march 2023.Lot 162692: (b)(4) items manufactured and released on 24-jun-2016.Expiration date: 2021-may-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional devices involved batch review performed on 24 march 2023 gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot 163309: (b)(4) items manufactured and released on 26-aug-2016.Expiration date: 2021-jul-25.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.07.0035rp patella resurfacing size 3 (k090988) lot 162487: (b)(4) items manufactured and released on 28-jul-2016.Expiration date: 2021-jul-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medacta medical affairs director: 6.25 years after primary cemented tka, the tibial tray subsides significantly and needs replacement.Normally, subsidence of tibial trays, particularly cemented ones, is due either to insufficient cortical coverage or to decreasing bone quality at metaphyseal tibia.In this case, though we were not given the postop xrays, we tend to think that the reason for subsidence is decreased bone quality, because insufficient coverage would not have granted 6 years of good performance.Therefore, there is no reason to suspect either a defective device or a technical error at the origin of this adverse event.Image investigation performed by medacta r&d knee manager: revision surgery of a gmk sphere implant after 6 years from primary implantation due to tibial subsidence.An image of the bone after explantation has been sent with the complaints.From the image sent, we can see that the tibial baseplate was sunk into the bone, in both sides but mainly in the lateral side.A re-modelling of the bone to accommodate the sinking of the baseplate can be noted.From investigation of the image sent, there is no evidence that the event is related to a faulty device.

Event Description

The patient came in reporting knee pain due to all implants being loose and the cause of the loose implants is unknown.About 6 years and 3 months after the primary surgery, the surgeon revised all components and the surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ R
• Type of Device: KNEE FEMUR CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16761594
• MDR Text Key: 313502759
• Report Number: 3005180920-2023-00264
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030862427
• UDI-Public: 07630030862427
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/18/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2021
• Device Model Number: 02.12.0025R
• Device Catalogue Number: 02.12.0025R
• Device Lot Number: 162692
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/24/2016
• 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): Required Intervention
• Patient Sex: Male