MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/12MM; KNEE TIBIAL INSERT FIXED

Catalog Number	02.07.0412PSF
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 march 2019 lot 120687: (b)(4) items manufactured and released on 27-apr-2012.Expiration date: 2017-03-31.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.Clinical evaluation performed by medical affairs department.Insert revision in tka 6 years and 5 months after primary for joint instability.The insert was exchanged to a thicker one.The developmental instability is a rather commonly described possible complication following tka, because soft tissue may stretch and provide insufficient stability.It is therefore common practice to resort to a thicker insert and recreate soft tissue tension.This is not a problem due to any implant defect or malfunction.Planning review performed by mysolution department: we analyzed each step of the myknee process.No errors have been found in the myknee process.Extra-analysis: we received two post-op x-rays: a frontal view and a lateral view.The quality of the images is quite low because of the following reasons: they are photos of a monitor showing a scan of some x-rays.These photos have been taken with not optimal lighting.Since the low quality, a very precise analysis is not possible.Anyway, we overlapped on the x-rays the 3d bone model of the tibial cut and the femur cut with the parameters of the validated revision and the planned sizes.Here below you can see the results comparison between the implanted tibia component and the validated planning: the implanted size is indeed a 4 the cut level seems substantially the planned one the component has been implanted with definitely less slope (the planned one was 4.0°) the ml position of the component seems substantially the planned one the ap position of the component seems substantially the planned one a slight residual valgus has been left (in the validated planning no residual deformity was set) here is our comparison between the implanted femoral component and the validated planning: the implanted size is indeed a 3.The distal cut seems substantially the planned one.The posterior cut seems substantially the planned one.The rotation of the component seems substantially the planned one.The flexum given to the component seems the planned one.The ml position of the component seems substantially the planned one.A slight residual varus has been left (in the validated planning no residual deformity was set) conclusions: our analysis of the myknee process of this case found no deviations from the standard procedures.Each step has been performed correctly.
Event or Problem Description
On (b)(6) we were informed about the revision surgery performed the day after due to knee instability (6 years and 5 months after primary), 12 mm ps inlay has been revised with a 17mm ps inlay.After the revision the knee was stable.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/12MM
• Common Device Name: KNEE TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8460367
• Report Number: 3005180920-2019-00201
• Device Sequence Number: 19597493
• Product Code: JWH
• UDI-Device Identifier: 07630030817748
• UDI-Public: 07630030817748
• 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: 2012
• 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): 03/28/2019

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: 03/31/2017
• Device Catalogue Number: 02.07.0412PSF
• Device Lot Number: 120687
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/28/2019
• 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 Age: 70 YR
• Patient Weight: 84