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

Catalog Number	02.12.T3I4R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08-august-2019: lot 123718: (b)(4) items manufactured and released on 4-feb-2013.Expiration date: 2017-12-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Preliminary investigation performed by r&d knee department manager revision surgery after 5 years from implantation due to knee pain in a overweight patient.Surgeon suspected of a mobilization of the tibia tray; this was then not confirmed.During the revision procedure the surgeon decided to remove and substitute tibial tray and liner.From preliminary investigation of the explanted components, no residual cement can be seen on the distal surface of the tibia tray.This is a common finding on explanted components even when loosening is not the cause for revision.So, absence of cement on explanted components is not an evidence of a faulty device.A fall and a suspicious of infection occurred about one year before revision; these events could also had played a role in the late loosening of the tibia tray.The tibial liner looks damaged, with dents and scratches in its distal surface most likely caused during the attempt to explant the liner.No other aspects relevant for the event can be noted on explanted components.
Event or Problem Description
Revision surgery performed after 5 years and 2 months due to pain caused by tibial tray loosening probably caused by a fall.The tibial tray and liner have been revised.
Additional Manufacturer Narrative
On november 21th 2019 we have received the screw involved in the complaint.Visual inspection performed by r&d knee manager: the preliminary investigation has been confirmed also during the visual inspection.No additional conclusions can be drawn."from preliminary investigation of the explanted components, no residual cement can be seen on the distal surface of the tibia tray.This is a common finding on explanted components even when loosening is not the cause for revision.So, absence of cement on explanted components is not an evidence of a faulty device.A fall and a suspicious of infection occurred about one year before revision; these events could also had played a role in the late loosening of the tibia tray.The tibial liner looks damaged, with dents and scratches in its distal surface most likely caused during the attempt to explant the liner.".

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8948720
• Report Number: 3005180920-2019-00717
• Device Sequence Number: 19473443
• Product Code: JWH
• UDI-Device Identifier: 07630030827143
• UDI-Public: 07630030827143
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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: 12/31/2017
• Device Catalogue Number: 02.12.T3I4R
• Device Lot Number: 123718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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
• Patient Age: 77 YR
• Patient Weight: 112