MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/12 MM L

Model Number	02.12.0612FL
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 18 september 2024: lot 2337090: (b)(4) items manufactured and released on 05-oct-2023.Expiration date: 2028-sep-23.To date, no items have been implanted.Additional implant involved, batch review performed on 18 september 2024: gmk-sphere 02.12.0611fl gmk-sphere tibial insert - flex s6l - 11 mm (k140826) lot 2337089: (b)(4) items manufactured and released on 05-oct-2023.Expiration date: 2028-sep-23.To date, one item has been implanted.Investigation performed by washing and packaging manager: a mix-up occurred between 2 lots, 2337090 and 2337089.In preparation for final packaging and upon completion of step 530 of the route cards, which were completed on 25-sept-2023, an operator error occurred, causing the pieces of lot 2337089 to be combined with the documentation of lot 2337090 (and vice versa).This was an isolated error involving a full and direct exchange between these two lots, caused by an oversight in execution of the procedure defined for the operation.Analysis of the production records confirms this occurrence was distinct to the lot numbers involved, with a full accounting of precisely (b)(4) pieces for each lot.All (b)(4) pieces of lot 2337089 were packaged with the labeling of lot 2337090, and all (b)(4) pieces of lot 2337090 were packaged with the labeling of lot 2337089.This results in all pieces being accounted for, and not opportunity for other pieces or lots to be affected by this occurrence.Capa file has been open to prevent a reoccurrence of the event.Recall was performed to remove the items from the market.Us was not involved as no items had been shipped there.
Event or Problem Description
During the surgery, a tibial insert 6-11mm (reference 02.12.0611fl lot 2337089) was found inside the box of a tibial insert 6-12mm labeled 02.12.0612fl lot 2337090.Another box of the same lot 2337090 was opened, and the same issue was found (the box contained 02.12.0611fl lot 2337089).Surgery completed with a cr 12 mm insert (another 12mm flex insert was not available).

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/12 MM L
• 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: 20470211
• Report Number: 3005180920-2024-00826
• Device Sequence Number: 12600879
• Product Code: JWH
• UDI-Device Identifier: 07630030826979
• UDI-Public: 07630030826979
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.12.0612FL
• Device Lot Number: 2337090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 103 KG