MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR PS CEMENTED SIZE 2 R; KNEE FEMUR CEMENTED

Catalog Number	02.07.2202R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 december 2019.Lot 102868: (b)(4) items manufactured and released on 30-sep-2010.Expiration date: 2015-08-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director: 8 years after tka, a secondary patella resurfacing surgery is undertaken, and then the original prosthesis is found loose and replaced.Aseptic loosening is a possible adverse event following total joint arthroplasty, described in literature, and causes remain often undetermined.We could find no hints in this case of a clear cause for loosening, but we do not see any reason to suspect a faulty device.Additional implant involved in the event, batch review performed on 04 december 2019.Gmk-primary 02.07.1202r tibial tray fixed cemented size 2 r (k090988) lot.111043.Lot 111043: (b)(4) items manufactured and released on 05-may-2011.Expiration date: 2016-03-31.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.
Event or Problem Description
The patient complained of pain in the knee, in the anterior region.When the surgeon opened the knee, he noticed loosening of the femoral component and loosening of the tibial implant, so everything was removed.It was noticed a large defect on the internal part of the femoral condyle.The surgeon did not notice anything about the rxs at his disposal.Unfortunately, a revision system was not available only a gmk primary (implants and instrumentation) was available.So the surgeon performed the revision with primary system and compensated the defects with cement 8 years after primary.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY FEMUR PS CEMENTED SIZE 2 R
• Common Device Name: KNEE FEMUR CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9479694
• Report Number: 3005180920-2019-01067
• Device Sequence Number: 13511674
• Product Code: JWH
• UDI-Device Identifier: 07630030820816
• UDI-Public: 07630030820816
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2019

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: 08/31/2015
• Device Catalogue Number: 02.07.2202R
• Device Lot Number: 102868
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/17/2019
• 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 Weight: 60