MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R; KNEE FEMORAL COMPONENT

Catalog Number	02.12.0002R
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 october 2019: lot 180957: 68 items manufactured and released on 15-may-2018.Expiration date: 2023-05-03.No anomalies found related to the problem.To date, 54 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director: 1 year after primary cemented tka the femur is exchanged to a revision component of smaller size and the patella is resurfaced.The anterior pain reported by the patient may be due to the excessive size of the primary femoral component and the empty volume between anterior shield and bone.No reason to suspect a faulty device in this case.
Event or Problem Description
The x-rays showed that the femoral implant in place was too big for the patient bone.The patient was revised 1 year after primary because had anterior knee pain.Femoral components swap and patella resurfacing performed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9284062
• Report Number: 3005180920-2019-00933
• Device Sequence Number: 19340638
• Product Code: JWH
• UDI-Device Identifier: 07630030825804
• UDI-Public: 07630030825804
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2019

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: 05/03/2023
• Device Catalogue Number: 02.12.0002R
• Device Lot Number: 180957
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 11/06/2019
• 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: 56 YR
• Patient Weight: 54