MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L; FEMORAL CEMENTED COMPONENT

Catalog Number	02.12.0003L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date, the final implants were not implanted yet.Batch review performed on 28 august 2018.Lot 177991: (b)(4) items manufactured and released on 22 january 2018.Expiration date: 2023-01-04 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.Others devices involved.Gmk-sphere reference 02.07.1202l (k090988) tibial tray fixed cemented size 2 l.Lot 177760: (b)(4) items manufactured and released on 28 february 2018.Expiration date: 2023-02-13 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.Reference 02.12.0211fl (k140826) tibial insert fixed sphere flex size 2/11 mm l.Lot 155638: (b)(4) items manufactured and released on 29 february 2016.Expiration date: 2021-02-01 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 reference 02.07.0033rp (k090988) patella resurfacing size 1.Lot 176695: (b)(4) items manufactured and released on 01 march 2018.Expiration date: 2023-02-14 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 surgeon removed the implant due to an infection 1 months and half after primary surgery.After that he implanted a spacer.The final revision has not been scheduled yet.After the removal of the devices, he found that the explanted component were not adhered completely to the bone cement in comparison with the competitor's one.He felt the adhesion strength of bone cement and our devices were too low.[(b)(6).].
Additional Manufacturer Narrative
Update october 09, 2018: no info about revision will become available.Visual inspection performed by r&d product manager on september 28, 2018.Revision surgery after about 1 month and a half from primary implantation for infection.No traces of residual cement can be seen on the distal surface of the explanted tibial baseplate and on the internal surface of the femoral component in contact with the bone.This is something usual to be seen on explanted components even if the cause of revision is not instability, loosening or mobilization.Therefore, lack of cement on the explanted components is not an evidence of lack of adhesion between the cement and the implant due to faulty devices.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L
• Common Device Name: FEMORAL CEMENTED COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7826827
• Report Number: 3005180920-2018-00634
• Device Sequence Number: 1287624
• Product Code: JWH
• UDI-Device Identifier: 07630030825811
• UDI-Public: 07630030825811
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/12/2018

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: 01/04/2023
• Device Catalogue Number: 02.12.0003L
• Device Lot Number: 177991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 10/12/2018
• 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