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

Model Number	02.12.0005R
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mix-up has been confirmed; a box labeled with the ref.02.12.0005r, lot 156067a, (gmk-sphere femoral component sphere cemented size 5 r) was found to include ref.02.12.0006l, lot 157067a (gmk-sphere femoral component sphere cemented size 6 l) and vice versa.The letters "a" is present at the end of the lot numbers because they are assigned in the re-sterilization processing of the lots, as per the medacta international internal procedures.Both lots involved in the action are composed of 1 device each.The item labeled ref.02.12.0006, lot 157067a has been located and quarantined.It was not in a hospital but in the medacta australia melbourne warehouse.Batch reviews performed on 28 march 2022 lot 156067a: (b)(4) item manufactured and released on 27-apr-2021.Expiration date: 2026-04-06.No anomalies found related to the problem.Lot 157067a: (b)(4) item manufactured and released on 27-apr-2021.Expiration date: 2026-04-06.No anomalies found related to the problem.Action has been taken within capa 006-21 to implement more precise process controls to prevent any potential recurrence of this issue.The verification of effectiveness requirements of the capa process will thoroughly evaluate and confirm the adequacy of the actions taken prior to capa closure.
Event or Problem Description
During a knee replacement surgery, a gmk sphere femoral component implant box size 5r was opened.The component was inserted with cement upon which the surgeon noticed a discrepancy between the trial and the definite implant, and then discovered that it was a left femoral component.The gmk sphere femoral component had to be removed, the cement was scraped away to check the size label inside the component.Instead of a 5r as per the label on the box and inside the package, it was a 6l.Because there was no back-up set available, another 5r had to be brought to the hospital from the south australian warehouse.The surgery got delayed by at least 40min, but was then successfully completed.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14167012
• Report Number: 3005180920-2022-00280
• Device Sequence Number: 14605626
• Product Code: JWH
• UDI-Device Identifier: 07630030825866
• UDI-Public: 07630030825866
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2026
• Device Model Number: 02.12.0005R
• Device Catalogue Number: 02.12.0005R
• Device Lot Number: 156067A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• 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: 62 YR
• Patient Sex: Male