MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 6 R

Model Number	02.07.1206R
Health Effect - Clinical Codes	Pain (1994); Joint Contracture (4528)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 november 2020.Lot#: 150361: 30 items manufactured, and released on 28-apr-2015.Expiration date: 2020-03-31.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 since 2016.Clinical evaluation one year after primary cemented tka the patient is painful and has a contracture.Revision surgery is carried out and both components are found mobile, with little interdigitation of the cement.Smaller implants are applied and new resections performed with a thicker insert.The cause for pain and contracture is not determined, it could have been due to the cement problem or sizing of the components.The fact that cement had poor adhesion to the components is most probably due to a problem with the cement or the cementation procedure (e.G.Temperature, timing, dryness of the surfaces, etc.).Visual inspection revision surgery of a gmk sphere implant due to pain and contracture.During the revision surgery, mobilization of the tibial and the femoral components were discovered.From visual inspection no residual cement can be seen on the implant surfaces in contact with the bone.Absence of cement on explanted components is not an evidence of faulty devices; lack of interdigitation can be most likely due to the cement itself or cementation problem.That being said, lack of cement can be usually noted on explanted components even if the cause for revision is not mobilization.Cause for pain and contracture are unknown.From visual inspection there is no evidence the event is related to a faulty device.Other devices involved in the event gmk-sphere 02.12.0026r femoral component sphere cemented size 6+ r lot.188939 (k140826) batch review performed on (b)(6) 2020; lot#: 188939: 53 items manufactured and released on 16-jan-2019.Expiration date: 2023-12-18.No anomalies found related to the problem.To date, 29 items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.12.0611fr tibial insert fixed sphere flex size 6/11 mm r lot.146659 (k140826) batch review performed on (b)(6) 2020; lot #: 146659: 25 items manufactured and released on 28-apr-2015.Expiration date: 2020-03-31.No anomalies found related to the problem.To date, 7 items of the same lot have been already sold without any other similar reported event since 2016.
Event or Problem Description
The patient hat pain and contractures on the knee, so the surgeon decided to change the inlay and eventually to change the tibia size to one smaller.During surgery femur component and tibia component were loose and came out really easily.No cement was stucked to the prosthesis.Everything was revised 1 year after primary.Teh suregeon sawed both the femoral and tibial bone in order to remove the cement (since all the cement was attached to the bone).As a result there was bone lose and a higher inlay was necessary to compensate.It is unknown if pain and contracture are related to the mobilization of the prosthesis.The contracture, on the other hand, is linked to the fact that the knee was very tight and the scar was very extensive and very thick.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 6 R
• Common Device Name: TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11028064
• Report Number: 3005180920-2020-00903
• Device Sequence Number: 13620236
• Product Code: JWH
• UDI-Device Identifier: 07630030819957
• UDI-Public: 07630030819957
• Combination Product (Y/N): Y
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 02.07.1206R
• Device Catalogue Number: 02.07.1206R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/17/2020
• 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