MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR CEMENTED PS SIZE 6 NARROW / LEFT; CEMENTED FEMORAL COMPONENT

Catalog Number	02.07.2216L
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 26 september 2017 the medical affairs director performed a clinical evaluation and commented as follows: total knee revision surgery occurred 1 year and 8 months after primary surgery.Radiographic images provided show the presence of a loosened tibial component: radiolucent lines are visible between cement and tibial component profile mainly in the posterior part of the tibial baseplate.Cement penetration on the tibial resection plane is very limited, and no cement remained attached to the explanted baseplate.This leads to think that impaction of the tibial baseplate encountered some problems: for instance, the cement had already cured more than expected at the time of impaction (perhaps due to higher-than-expected temperature in the room), or the presence of cement distal to the central stem prevented the component from reaching final seating.The sagittal plane view also shows an incomplete resection posteriorly, which probably had little or no influence in the problems of tibial seating.The root cause of the problem cannot be determined with certainty but it is extremely unlikely that it was due to a defective implant.Batch reviews performed on 02 october 2017.(b)(4).On 06 october 2017 the r and d project manager performed a preliminary investigation based on the available pictures, and commented as follows: some residual cement is present on the internal surfaces of the femoral component (parts of bone still adhere to the cement after implant removal).The femoral component seems to be in compliance with the specifications required in terms of internal surface finishing.No residual cement is present on the bottom plan of the tibial tray.No anomalies have been noted on the explanted component.The surface quality of the bottom plane of the device seems to match with the specification (even when compared to the surface quality of the internal surfaces of the explanted femoral component), but with only the picture in our hand it is not possible to accurately check it.It is not possible to suppose any possible root causes for the event.No other considerations can be done looking at the picture of the explanted components.The root cause of the problem cannot be determined with certainty but it is extremely unlikely that it was due to a defective implant.
Event or Problem Description
The patient came in complaining of instability.Upon removal of the components the surgeon determined the cement did not adhere to the tibial baseplate.The surgeon revised the femur, insert and tibial tray.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY FEMUR CEMENTED PS SIZE 6 NARROW / LEFT
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6921702
• Report Number: 3005180920-2017-00554
• Device Sequence Number: 16495964
• Product Code: JWH
• UDI-Device Identifier: 07630030821028
• UDI-Public: 07630030821028
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2017

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: 03/31/2020
• Device Catalogue Number: 02.07.2216L
• Device Lot Number: 151535
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 10/06/2017
• 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
• Patient Age: 68 YR