MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5 R; KNEE CEMENTED FEMUR

Model Number	02.12.0005R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 february 2020: lot 186210: (b)(4) items manufactured and released on 02-oct-2018.Expiration date: 2023-09-20.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.Patient match planning review performed by medacta mysolution: primary c_mar_rsk_gm_26051959.We analyzed each step of the myknee process; no errors have been found.Here below you can find the detailed analysis of the process: images qc: the dataset fully respects the protocol.The images were not expired at the time of the surgery.Reconstruction: the reconstructed profile follows precisely the contour of the bone.Planning - landmarks: all the landmarks were taken accordingly to the process.Pre-op information: as per the other cases, the only information available to the my knee team was about the bones.No pre-op information was available regarding: the status of the ligaments: this information, as for all the cases, is available just to the surgeon.The thickness of the cartilage: this information is not available, since this case is ct- based.Planning proposal: in the planning proposal, all the chosen parameters are within the range of preferences set by the surgeon on the website.Planning - validation: our planning proposal has been validated by the surgeon, without any changes in the parameters.Planning- choice of the size: we proposed a size 5 for the femur and a size 5 for the tibia.The surgeon implanted the chosen size on the femur, while he implanted a size 4 on the tibia.Femoral cutting block: all the pads are in contact with parts that cannot get detached.Tibial cutting block: all the pads are in contact with parts that cannot get detached.Femoral implant positioning: the prosthesis would fit with the parameters of the validated revision.Tibial implant positioning: the prosthesis would fit with the parameters of the validated revision.Extra-analysis: no extra-analysis is possible, since we have not received any x-ray.Conclusions: our analysis of the myknee process of this case found no deviations from the standard procedures.Each step has been performed correctly.Revision c_mar_rsk_jm_26051959: we analyzed each step of the myknee process; no errors have been found.Here below you can find the detailed analysis of the process: images qc: the dataset fully respects the protocol.The images were not expired at the time of the surgery.Reconstruction: the reconstructed profile follows precisely the contour of the bone and relative implant.Planning - landmarks: all the landmarks were taken accordingly to the process pre-op information: as per the other cases, the only information available to the my knee team was about the bones.No pre-op information was available regarding: the status of the ligaments: this information, as for all the cases, is available just to the surgeon.The thickness of the cartilage: this information is not available, since this case is ct- based.Planning proposal: this is a post-op revision case, therefore no myknee cutting blocks has been produced.For this cases we perform only a planning evaluation.Extra-analysis: no extra-analysis is possible, since we have not received any x-ray 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
Loosening of the tibial plate (no infection).All devices were revised and a gmk-revision system was implanted almost 1 year and 1 month after primary.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5 R
• Common Device Name: KNEE CEMENTED FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9769299
• Report Number: 3005180920-2020-00110
• Device Sequence Number: 16307041
• Product Code: JWH
• UDI-Device Identifier: 07630030825866
• UDI-Public: 07630030825866
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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: 09/20/2023
• Device Model Number: 02.12.0005R
• Device Catalogue Number: 02.12.0005R
• Device Lot Number: 186121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/28/2020
• 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
• Patient Weight: 75