MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 R; TIBIAL TRAY FIXED

Catalog Number	02.07.0684R
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on december 12 2019: lot 1902920: (b)(4) items manufactured and released on 25-sep-2019.Expiration date: 2024-09-17.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.All available items of lot 1902920 have been re-inspected and verified to be in compliance with the specifications.The case is isolated to only one piece of the lot.Visual inspection performed by r&d knee manager: during revision surgery, after having already cemented all the tibia semi-constrained construct (baseplate, cone, offset, stem, and medial/lateral tibial augments), the surgeon tried to assemble the semi-constrained insert.The insert couldn't completely engage it into the baseplate.The surgeon tried another 2 times with 2 new tibial inserts without success.The surgeon then observed intraoperatively that the tibia baseplate posterior locking mechanism was not machined.From visual inspection of the returned tibial baseplate, we can confirm that the posterior features for the locking mechanism of the tibial insert are partially machined.From functional inspection with dedicated gauge, it is possible to confirm that the insert could not engage in the baseplate.The root cause for incomplete machining of the posterior locking mechanism is related to a milling tool breakage during machining followed by ineffective / incomplete containment and inspection of the effected unit.
Event or Problem Description
The surgeon attempted to lock the semi-constrained poly into the tibia but it was not possible.After 20 minutes, the agent opened up another semi-constrained poly for the surgeon to use, and that did not lock in either.The agent opened then a ps poly and it didn't seat either.The surgeon observed that the tibia baseplate locking mechanism wasn't machined in to have the poly locked into it.The surgeon decided at this point to explant the whole tibial construct (baseplate, cone, offset, stem, and medial/lateral tibial augments) and replaced the components with a new baseplate, cone, offset, stem, and medial/lateral tibial augments, and upsized tibial baseplate and a semi-constrained poly.The surgery was completed successfully.There was a 50-minute delay in the case.Additional anaesthesia was not used.

• Brand Name: GMK-REVISION REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 R
• Common Device Name: TIBIAL TRAY FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9494243
• Report Number: 3005180920-2019-01090
• Device Sequence Number: 10827776
• Product Code: JWH
• UDI-Device Identifier: 07630030819391
• UDI-Public: 07630030819391
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K123721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/17/2024
• Device Catalogue Number: 02.07.0684R
• Device Lot Number: 1902920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 12/19/2019
• 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