MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R; KNEE CEMENTED FEMORAL COMPONENT

Catalog Number	02.12.0024R
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 may 2019: lot 166936: (b)(4) items manufactured and released on 10-jan-2017.Expiration date: 2021-12-19.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 implants involved: gmk-sphere 02.12.0410fr tibial insert fixed sphere flex size 4/10 mm r (k121416) lot 174805: (b)(4) items manufactured and released on 28-jul-2017.Expiration date: 2022-07-16.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.Gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 (k090988) lot 179514: (b)(4) items manufactured and released on 03-may-2018.Expiration date: 2023-04-23.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.Gmk-sphere 02.07.0035rp patella resurfacing size 3 (k090988) lot 180313: (b)(4) items manufactured and released on 03-may-2018.Expiration date: 2023-04-22.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.Clinical evaluation performed by medacta medical director: according to report, this primary tka patient laments a grinding feeling when bending her knee.The hypothesis of a backed-out screw has been rejected, this is not the problem.Therefore, we do not have enough information to formulate a clinical analysis.Apparently, no revision has been made or scheduled.
Event or Problem Description
The patient came in complaining of pain and grinding in the knee joint, after 8 months form the primary.The cause of the pain and grinding is unknown.No revision surgery has been scheduled at this time.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R
• Common Device Name: KNEE CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8619674
• Report Number: 3005180920-2019-00382
• Device Sequence Number: 13974773
• Product Code: JWH
• UDI-Device Identifier: 07630030862403
• UDI-Public: 07630030862403
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2019

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: 12/19/2021
• Device Catalogue Number: 02.12.0024R
• Device Lot Number: 166936
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 05/17/2019
• 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: Other