MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R; POLYETHYLENE KNEE INSERT

Catalog Number	02.12.0210FR
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information provided by the agent on (b)(4) 2019: the surgery has not been performed yet.The plan is to remove the loose screw.Clinical evaluation performed by medacta medical manager: during 4 year follow-up, radiographic images show the presence of a loosened insert screw.This event may be caused by insufficient tightening torque but this cannot be confirmed.Immediate removal and visual inspection of articular surfaces is strongly recommended.No negative consequences should be expected for the patient or the duration of the implant, which can work properly even in the absence of the insert screw.
Event or Problem Description
On (b)(6) 2019 we were informed about a patient who will need an arthroscopic removal of the inlay locking screw, after about 4 years from implantation, due to screw unscrewing.Patient is not having any pain.
Additional Manufacturer Narrative
On july 2nd we have received this additional information: the patient has decided not to have any revision as he is not experiencing any problems.Batch review performed on 03 july 2019: lot 144269: (b)(4) manufactured and released on (b)(4) 2014.Expiration date: 2019-07-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with a similar reported event.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R
• Common Device Name: POLYETHYLENE KNEE INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8573543
• Report Number: 3005180920-2019-00335
• Device Sequence Number: 13516582
• Product Code: JWH
• UDI-Device Identifier: 07630030826146
• UDI-Public: 07630030826146
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 07/31/2019
• Device Catalogue Number: 02.12.0210FR
• Device Lot Number: 144269
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 07/30/2019
• 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: 73 YR
• Patient Weight: 70