MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

Catalog Number	02.12.T3I4L
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	12/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 january 2019.Lot 175636: (b)(4) items manufactured and released on 30 may 2017.Expiration date: 06.11.2022 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 femoral component sphere cemented size 4+ l reference 02.12.0024l (k140826).Lot: 173652: (b)(4) items manufactured and released on 13 september 2017.Expiration date: 2022-08-29.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 tibial insert fixed sphere flex size 4/13 mm l reference 02.12.0413fl (k140826).Lot 173652: (b)(4) items manufactured and released on 13 september 2017.Expiration date: 2022-08-29.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.Preliminary investigation based on the pictures of the explanted components performed by r&d product manager: revision surgery for infection after 1 year from primary implantation and 3 months after a first revision surgery for a poly swap due to pain.No traces of residual cement can be seen on the tibial tray.Some residual bone can be seen on the internal distal medial surface of the femoral component.There is no evidence that poor inter-digitation between cement and implant is an infection promoting factor.
Event or Problem Description
The patient came in 8 months after primary surgery due to pain.A poly swap was performed (see mdr 2018-00786).Now, 3 month and a half after the first revision surgery, the patient came in due to infection.The surgeon revised all the implants and the surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L
• Common Device Name: TIBIAL TRAY FIXED CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8288676
• Report Number: 3005180920-2019-00013
• Device Sequence Number: 13939739
• Product Code: JWH
• UDI-Device Identifier: 07630030827136
• UDI-Public: 07630030827136
• 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
• Report Date (Section B): 01/30/2019

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: 06/11/2022
• Device Catalogue Number: 02.12.T3I4L
• Device Lot Number: 175636
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 01/30/2019
• 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: Required Intervention