MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE PATELLA RESURFACING SIZE 4

Model Number	02.07.0036RP
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 february 2020: lot 160955: (b)(4) items manufactured and released on 12-may-2016.Expiration date: 2021-04-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient had a primary knee surgery in 2014, and was implanted with competitor components.On (b)(6) 2016, the patient came in to have the competitor products revised.The surgeon revised the patient with medacta components.Presently, 3 years and 6 months after primary surgery, it has been made aware that the patient is in need of a revision due to partial dislocation of the patella.The cause of this is unknown.A revision surgery has not been scheduled yet.More details to follow when information becomes available.

• Brand Name: GMK-SPHERE PATELLA RESURFACING SIZE 4
• Common Device Name: PATELLA RESURFACING
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9768502
• Report Number: 3005180920-2020-00104
• Device Sequence Number: 654155
• Product Code: JWH
• UDI-Device Identifier: 07630030815775
• UDI-Public: 07630030815775
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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: 04/21/2021
• Device Model Number: 02.07.0036RP
• Device Catalogue Number: 02.07.0036RP
• Device Lot Number: 160955
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/28/2020
• 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: Other