MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R

Model Number	02.12.0024R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 june 2020: lot 184863: (b)(4) items manufactured and released on 27-sept-2018.Expiration date: 2023-09-16.No anomalies found related to the problem.To date, 38 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director: knee revision surgery performed 1.5 years after cemented total knee arthroplasty in an elderly woman ((b)(6)).According to the report, the patient was affected by severe systemic diseases (asa 3) but no additional information was provided.Poor quality of the single image provided does not allow to draw any conclusion.No reason to suspect a faulty device.Mysolution analysis: case (b)(4) was analysed.The implanted size of the femur seems the same planned.Seems that the implanted sizes has less flexum than the planned one.The implanted size of the tibia seems the same planned.Seems that the implanted sizes has less slope than the planned one.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
1 year and 5 months after primary surgery the patient had knee pain and the surgeon suspected of tibial tray loosening.The surgeon revised the joint finding no tibial tray loosening, but the femur was loose.The surgeon revised all implants successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R
• Common Device Name: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10288433
• Report Number: 3005180920-2020-00420
• Device Sequence Number: 16377743
• Product Code: JWH
• UDI-Device Identifier: 07630030862403
• UDI-Public: 07630030862403
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2020

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 Expiration Date: 09/16/2023
• Device Model Number: 02.12.0024R
• Device Catalogue Number: 02.12.0024R
• Device Lot Number: 184863
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Weight: 75