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

Model Number	02.12.0024L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 december 2021.Lot 171808: (b)(4) items manufactured and released on 10-jul-2017.Expiration date: 2022-jun-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Additional implant involved: gmk-sphere 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot.171944.Batch review performed on 17 december 2021.Lot 171944: (b)(4) items manufactured and released on 12-jul-2017.Expiration date: 2022-jun-26.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event.Preliminary investigation performed by r&d project manager.Revision surgery of a gmk sphere implant after 1 year from primary implantation for loosening of the tibia component.From pictures of the explanted component, no residual cement can be identified on the distal surface of the tibia tray.Surface finishing of the tibia baseplate seems to be in compliance with the specifications required.Lack of adhesion between the cement and the implant is not an evidence of a faulty device.Poor cement inter-digitation on the implant surface are of various origin; they could be related to the cement and cementation procedure or mobilization of the implant during curing.From preliminary investigation, there is no evidence that the event is related to a faulty device.
Event or Problem Description
Revision surgery performed about 1 year and 1 month due to tibial and femoral component loosening.The surgeon commented that no cement was attached to femoral and tibial implants implanted in primary surgery and that implant fixation is poor.All components revised.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13222353
• Report Number: 3005180920-2022-00009
• Device Sequence Number: 4663430
• Product Code: JWH
• UDI-Device Identifier: 07630030862397
• UDI-Public: 07630030862397
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2022

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: 06/29/2022
• Device Model Number: 02.12.0024L
• Device Catalogue Number: 02.12.0024L
• Device Lot Number: 171808
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian