MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R; KNEE FEMORAL COMPONENT

Model Number	02.12.0023R
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 february 2023.Lot 2210192: (b)(4) items manufactured and released on 12-jul-2022.Expiration date: 2027-jul-03.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 item involved in the event, batch review performed on 02 february 2023: gmk-sphere 02.07.0034rp patella resurfacing size 2 (k090988) lot.2209919.Lot 2209919: (b)(4) items manufactured and released on 13-jul-2022.Expiration date: 2027-jun-20.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.
Event or Problem Description
About 1 month and 10 days after primary surgery, the patient came in reporting pain due to a capsule tear, dislocated patella implant, and subsided femoral component.The patella dislocated due to the capsule tear and subsidence of the femoral component, which caused the rotation to be off.The surgeon believes this happened because the patient had a soft bone.The surgeon revised all components to revision system (patella implant not revised).
Additional Manufacturer Narrative
The event description has been modified to report that the tibial component has not been revised.
Event or Problem Description
About 1 month and 10 days after primary surgery, the patient came in reporting pain due to a capsule tear, dislocated patella implant, and subsided femoral component.The patella dislocated due to the capsule tear and subsidence of the femoral component, which caused the rotation to be off.The surgeon believes this happened because the patient had a soft bone.The surgeon revised femur and insert to revision system (patella implant not revised).

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R
• Common Device Name: KNEE FEMORAL COMPONENT
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16467869
• Report Number: 3005180920-2023-00094
• Device Sequence Number: 5263150
• Product Code: JWH
• UDI-Device Identifier: 07630030862380
• UDI-Public: 07630030862380
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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 Model Number: 02.12.0023R
• Device Catalogue Number: 02.12.0023R
• Device Lot Number: 2210192
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2022
• 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: Female