MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TIBIAL BASE PLATE; FIXED CEMENTED TIBIAL TRAY

Catalog Number	02.07.1201L
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 22 dec 2017 the medical affairs made the following analysis: the images supplied are of extremely poor quality and do not allow proper evaluation.The tibial plateau seems to be placed medial and posterior, with a lateral weakening of the supporting tibial bone, but this is more guessing that assessing.The relationship between this position, which may be due to anatomical constraints not detectable from the xrays supplied, is unknown.Batch review performed on 02 january 2018: lot 091670: (b)(4) items manufactured and released on 21 august 2009.Expiration date: 2014-06-30.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Preliminary investigation based on the picture of the explanted component, made on 03 jan 2018 by r&d project manager: no residual cement can be seen on the bottom surface of the tibia baseplate.It is something usual to be seen on explanted components, even if the cause of revision is not loosening or mobilization.Some residual material can be seen surrounding the tibia keel, but it is not clear from the image if it is cement or bone.No further comments or considerations can be done looking at the picture sent.
Event or Problem Description
The patient came in complaining of pain.The surgeon determined the tibial baseplate had subsided.The surgeon revised the tibial baseplate and the poly.The surgery was completed successfully.

• Brand Name: GMK TIBIAL BASE PLATE
• Common Device Name: FIXED CEMENTED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7163357
• Report Number: 3005180920-2017-00810
• Device Sequence Number: 1952372
• Product Code: JWH
• UDI-Device Identifier: 07630030819841
• UDI-Public: 07630030819841
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2018

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: 06/30/2014
• Device Catalogue Number: 02.07.1201L
• Device Lot Number: 091670
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 01/04/2018
• 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
• Patient Age: 60 YR