MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM L; FIXED TIBIAL INSERT

Model Number	02.12.0313FL
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13-jul-2020.Lot 146603: (b)(4) items manufactured and released on 21 january 2015.Expiration date: 30-nov-2019.No anomalies found related to the problem.To date, 15 items of the same lot have been already sold without any similar reported event since 2016.Additional implant involved: gmk-sphere 02.12.0310fl tibial insert fixed sphere flex size 3/10 mm l (k121416) lot.155438.Implanted on the (b)(6) 2016 and revised on (b)(6) 2017.Batch review performed on 13-jul-2020.Lot 155438: (b)(4) items manufactured and released on 20 january 2016.Expiration date: 2021-01-09.No anomalies found related to the problem.To date, 59 items of the same lot have been already sold without any similar reported event since 2016.Additional implant involved: gmk-sphere 02.07.1203l tibial tray fixed cemented size 3 l (k090988) lot.155590.Implanted on (b)(6) 2016 and revised on (b)(6) 2020.Batch review performed on 13-jul-2020: lot 155590: (b)(4) items manufactured and released on 01-dec-2015.Expiration date: 2020-11-11.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event since 2016.Patient match planning review performed by my solution department 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: : the rev.1 has been validated by the surgeon.Planning- choice of the size: we proposed a size 3 for both the femur and the tibia.Regarding the femur, no information are available about the implanted size.Concerning the tibia, the surgeon implanted the proposed size.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.Conclusions: our analysis of the myknee process of this case found no deviations from the standard procedures.Each step has been performed correctly.Clinical evaluation performed by medical affairs director: tibial component re- revision due to recurrent instability performed 3 years after last operation.The developmental instability is a rather commonly described possible complication following tka, because soft tissue may stretch and provide insufficient stability.
Event or Problem Description
The first operation was on (b)(6) 2015, gmk-uni.On (b)(6) 2016 the gmk-uni was revised due to loosening of the femoral component, a gmk-sphere was implanted.On (b)(6) 2017, due to laxity, the 10 mm inlay has been revised with a 13 mm inlay.Due to persistent laxity problem in extension, without pain, on (b)(6) 2020 the tibia and inlay have been revised, a revision s.2 tibia with bilateral shims (s2.5mm), tibial extension stem (s.13 65mm) with offset (3mm) and reduction with s.2 14mm inlay were used for the revision surgery.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM L
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10282362
• Report Number: 3005180920-2020-00409
• Device Sequence Number: 485094
• Product Code: JWH
• UDI-Device Identifier: 07630030862571
• UDI-Public: 07630030862571
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 07/16/2020

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: 11/30/2019
• Device Model Number: 02.12.0313FL
• Device Catalogue Number: 02.12.0313FL
• Device Lot Number: 146603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/16/2020
• 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: 51 YR
• Patient Weight: 81