MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/20 MM L; KNEE TIBIAL INSERT

Catalog Number	02.12.0120FL
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 november 2018: lot 154729: (b)(4) items manufactured and released on 31 may 2016.Expiration date: 2020-12-12.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.Clinical evaluation performed by medical affairs director: one month after polyethylene liner exchange due to knee laxity, the insert fixation screw was found broken.Immediate removal is strongly recommended.We could not determine whether this event was originated during the poly-swap surgery.It is very unlikely that a fatigue fracture may have originated in such a short time, so the intrasurgical hypothesis is more credible, unless an unreported traumatic or quasi-traumatic event generated the situation.We do not have enough elements at hand to draw a final conclusion.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2017.The patient came in due to laxity and the surgeon performed a poly swap on (b)(6) 2018 [complaint (b)(4)].The surgeon took an x-ray for a post-op follow up and noticed that the insert screw was broken.The revision surgery will take place on (b)(6) 2018.
Additional Manufacturer Narrative
Update november 27, 2018.The surgeon removed the screw via scope.No implants were revised and the surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/20 MM L
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8084542
• Report Number: 3005180920-2018-00923
• Device Sequence Number: 1721156
• Product Code: JWH
• UDI-Device Identifier: 07630030826092
• UDI-Public: 07630030826092
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2018

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: 12/12/2020
• Device Catalogue Number: 02.12.0120FL
• Device Lot Number: 154729
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 12/27/2018
• 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