MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR CEMENTED PS SIZE 4NARROW / RIGHT; KNEE CEMENTED FEMUR

Model Number	02.07.2214R
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18-oct-2022: lot 2201232: (b)(4) items manufactured and released on 12-apr-2022.Expiration date: 2027-mar-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Additional device involved: batch review performed on 18-oct-2022: gmk-primary 02.07.0312psf tibial insert ps fixed size 3/12mm (k090988) lot 2204254: (b)(4) items manufactured and released on 27-may-2022.Expiration date: 2027-may-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation: few days after primary tka in 78 year old woman, the joint is not stable in spite of a seemingly correct position and revision is undertaken.Stability cannot be achieved even using thicker inserts and therefore a constrained prosthesis is chosen and implanted.It's possible that the original tibia cut was performed a little too low, but this could be compensated by a thicker insert.The absence of stability both lateral and posterior leads to think of a deficiency of the soft tissues, particularly ligaments and capsule.This revision was not due to a defective device.Analysis performed by mysolution project manager: our analysis of the myknee process of this case found no deviations from the standard procedures.Each step has been performed correctly.
Event or Problem Description
At about 3 days after the primary surgery, the patient luxated her knee.During the revision, it was not possible to restore the correct stability by using inlays with different thickness, so the whole prosthesis was removed and a hinge system was successfully implanted.

• Brand Name: GMK-PRIMARY FEMUR CEMENTED PS SIZE 4NARROW / RIGHT
• Common Device Name: KNEE CEMENTED FEMUR
• 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: 15679061
• Report Number: 3005180920-2022-00786
• Device Sequence Number: 7975085
• Product Code: JWH
• UDI-Device Identifier: 07630030820991
• UDI-Public: 07630030820991
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K122232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.07.2214R
• Device Catalogue Number: 02.07.2214R
• Device Lot Number: 2201232
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2022
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White