MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE PATELLA RESURFACING SIZE 2

Model Number 02.07.0034RP

Device Problems Fracture (1260); Device Slipped (1584)

Patient Problem Joint Disorder (2373)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 10 march 2020: lot 182983: (b)(4) items manufactured and released on 12-july-2018.Expiration date: 2023-07-11.No anomalies found related to both problems.To date, (b)(4) items of the same lot have been already sold without any other similar reported event for both problems.Clinical evaluation: replacement of prosthetic patella in tkr due to patellar bone fracture which caused loosening of the implant.The patient reported no trauma, nonetheless the cause for this event cannot be ascribed to a faulty device.

Event Description

Total knee prosthesis performed on (b)(6) 2018, without doing the patella.The patient subsequently reported pain and patella was resurfaced on (b)(6) 2018.After it, the patient reported again pain.An x-ray showed a bone fragment.The patient had a bone scan in january 2020 and this showed a loosening of the patella.Revision was necessary 1 year and 4 months after primary.During the washing of the patella and before cementing, a line of medio-lateral fracture was noticed.Reduction of the fracture with 2 pins and strapping before cementing the new implant.Only during revision it was discovered that bone fragment came from the patella.

• Brand Name: GMK-SPHERE PATELLA RESURFACING SIZE 2
• Type of Device: PATELLA RESURFACING
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874, sz; SZ
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 -CHE ; SZ 6874 CHE
• MDR Report Key: 9909607
• MDR Text Key: 192067029
• Report Number: 3005180920-2020-00205
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030815751
• UDI-Public: 07630030815751
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K090988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2020

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: No Information
• Device Expiration Date: 07/11/2023
• Device Model Number: 02.07.0034RP
• Device Catalogue Number: 02.07.0034RP
• Device Lot Number: 182983
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 04/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2018
• 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 Age: 71 YR
• Patient Weight: 65