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

Catalog Number	02.12.0003L
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 04 april 2024: gmk-sphere 02.12.0003l femoral component sphere cemented size 3 l lot 2349204: 15 items manufactured and released on 31-jan-2024.Expiration date: 2029-01-16.Of this lot 7 items were under control in a medacta warehouse.They have been immediately opened finding the 2 remaining mixed items (the third one is the subject of this complaint).Gmk-sphere 02.12.0003r femoral component sphere cemented size 3 r lot 2348382: 15 items manufactured and released on 31-jan-2024.Expiration date: 2029-01-16.The entire lot was in medacta international warehouse.All pieces were checked confirming that 3 devices of this lot were mixed up.It means that 3 devices of the lot 2349204 (size 3l) were found in the boxes of the lot 2348382 (size 3r).Preliminary investigation performed by washing and packaging manager: the issue probably occurred when loading or unloading the implants into the biowash, a machine used for cleaning.Both batches involved are composed by 15 pieces, while the racks dedicated to wash these components (femur size 3) hold a maximum of 12 pieces.Therefore, the remaining 3 pieces were placed in another rack and during the unloading phase, 3 pieces for each lot were mixed-up.In addition, during the batch inspection, the operator did not recognise the mix up.Internal actions, including training operators and updating work instruction, have been taken to prevent a reoccurrence of the event.
Event or Problem Description
A femur 3r was found inside a box labelled 3l.During the surgery, the surgeon put the femur with cement on the patient bone and as soon as positioned recognized the issue.A new femur was opened and implanted.The soft cement was removed from bone and a new left femur was implanted.There were 10 minutes of delay due to this.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19141610
• Report Number: 3005180920-2024-00154
• Device Sequence Number: 15314327
• Product Code: JWH
• UDI-Device Identifier: 07630030825811
• UDI-Public: 07630030825811
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 04/19/2024

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 Catalogue Number: 02.12.0003L
• Device Lot Number: 2349204
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2024
• 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: Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White