MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 3/10 MM R; FIXED TIBIAL INSERT

Model Number	02.12.0310CRR
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Discomfort (2330)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 july 2020: lot 185614: (b)(4) items manufactured and released on 27-sep-2018.Expiration date: 2023-09-16.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.Additional implant involved: gmk-sphere 02.12.0023r femoral component sphere cemented size 3+ r (k140826) lot.187175.Batch review performed on 29 july 2020: lot 187175: (b)(4) items manufactured and released on 29-nov-2018.Expiration date: 2023-11-20.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.Additional implant involved: gmk-sphere 02.07.1203r tibial tray fixed cemented size 3 r (k090988) lot.187296.Batch review performed on 29 july 2020: lot 187296: (b)(4) items manufactured and released on 17-jan-2019.Expiration date: 2024-01-08.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.Additional implant involved: gmk-sphere 02.07.0034rp patella resurfacing size 2 (k090988) lot.1900600.Batch review performed on 29 july 2020: lot 1900600: (b)(4) items manufactured and released on 07-may-2019.Expiration date: 2024-04-22.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 reporting discomfort due to developing an allergic reaction.The surgeon removed all components and replace them with oxinium competitor implants.The surgery was completed successfully 11 months after primary.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 3/10 MM R
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10366325
• Report Number: 3005180920-2020-00522
• Device Sequence Number: 2345183
• Product Code: JWH
• UDI-Device Identifier: 07630040707343
• UDI-Public: 07630040707343
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2020

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: 09/16/2023
• Device Model Number: 02.12.0310CRR
• Device Catalogue Number: 02.12.0310CRR
• Device Lot Number: 185614
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/05/2020
• 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: Required Intervention