MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM R; KNEE TIBIAL INSERT

Catalog Number	02.12.0413FR
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	08/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 6 september 2019: lot 187260: (b)(4) items manufactured and released on 20-dec-2018.Expiration date: 2023-12-09.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 came in, 2 weeks after primary surgery, for a follow-up appointment and post-op x-rays were taken.The post-op x-rays indicated that the poly-insert was not seated and locked into the baseplate.The surgeon revised the medacta sphere insert flex right 13 mm s4 with a medacta sphere insert flex right 13 mm s4.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM R
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9128853
• Report Number: 3005180920-2019-00822
• Device Sequence Number: 2615051
• Product Code: JWH
• UDI-Device Identifier: 07630030862632
• UDI-Public: 07630030862632
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/09/2023
• Device Catalogue Number: 02.12.0413FR
• Device Lot Number: 187260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/27/2019
• 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