MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 LEFT

Catalog Number	02.07.0682L
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 20 october 2017 the medical affairs performed a clinical evaluation and commented as follows: five months after implantation the patient was complaining about pain.Radiographic images provided show a suboptimal position of the tibial component.The reason of this position is unknown: the complexity of the preoperative status of the knee may have contributed but this cannot be assessed as preoperative xrays are not available.Batch reviews performed on 30 october 2017.Lot 165081: (b)(4) items manufactured and released on 19 october 2016.Expiration date: 2021-10-10.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-revision offset connector 3 mm, code 02.07.0003, lot.165116 (k102437) (b)(4) items manufactured and released on 11 november 2016.Expiration date: 2021-10-30.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 patient came in complaining of pain.The surgeon determined that the tibial tray was malrotated.The surgeon revised the tibial tray, insert, tibial augments, an extension stem, and offset connector.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 LEFT
• Common Device Name: FIXED TIBIAL TRAY CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6990603
• Report Number: 3005180920-2017-00628
• Device Sequence Number: 684155
• Product Code: JWH
• UDI-Device Identifier: 07630030819346
• UDI-Public: 07630030819346
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2017

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: 10/10/2021
• Device Catalogue Number: 02.07.0682L
• Device Lot Number: 165081
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/31/2017
• 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