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

Model Number	02.12.0025R
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005180920-2023-00264
• Device Sequence Number: 14218990
• Product Code: JWH
• UDI-Device Identifier: 07630030862427
• UDI-Public: 07630030862427
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male