MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

Model Number	02.12.0023R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08-jan-2020.Lot 179619: (b)(4) items manufactured and released on 18-apr-2018.Expiration date: 08/04/2023.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Additional implant involved: gmk-sphere 02.07.1203r tibial tray fixed cemented size 3 r (k090988) lot.176246.Batch review performed on 08-jan-2020.Lot 176246: (b)(4) items manufactured and released on 28-nov-2017.Expiration date: 2022-11-14.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.Additional implant involved: gmk-sphere 02.12.0311fr tibial insert fixed sphere flex size 3/13 mm r (k140826) lot.1811488.Batch review performed on 08-jan-2020.Lot 1811488:(b)(4) items manufactured and released on 02-apr-2019.Expiration date: 19.03.2024.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 director.Tka revision due to infection.We do not know how long after primary surgery this happened.The tibial insert appears to be not engaged to the tibial tray.As we have no other radiographs, we cannot determine when this happened either and if the insert was fully engaged at primary surgery, so we are unable to properly categorize this event.Preliminary investigation performed by r&d project manager.Revision surgery after 2 months from primary implantation for infection.During revision, the surgeon noticed that the tibial insert was not engaged in the baseplate.Insert fixation screw was not used.From the picture of the explanted components, the distal posterior medial surface of the tibial insert looks damaged; the medial posterior clipping feature of the insert seems to be bended and deformed.This confirms that the insert was not properly engaged into the baseplate in the posterior part.There is no evidence that the insert was properly engaged intra-op during primary surgery and its disengagement occurred post-op after primary surgery.We can only suppose that the insert was not properly fixed during primary surgery.We ask to send back the explanted insert for further investigation.
Event or Problem Description
Revision surgery performed due to infection, during the surgery it was noticed that the tibial insert was disengaged from the tibial tray.Fixation screw was not used in primary surgery.
Additional Manufacturer Narrative
Visual inspection performed by medacta knee r&d project manager: revision surgery performed 2 months after primary tka, due to signs of infection.During the revision surgery has been noted that tibial insert was not clipped into the tibial tray.No sign, that might suggest that tibial insert has been clipped during primary surgery, can be found on the surface of the explanted tibial insert.Neither the posterior snapping features (posterior lips) nor the anterior one (the elastic bridge) appear deformed has expected for an explanted tibial insert.If the insert should have been clipped during primary surgery, at least the anterior elastic bridge should have some sign of plastic deformation or scratches due to the anterior "tooth" of the tibial tray.We can suppose that probably the insert has not been clipped during primary surgery.Based on the inspection of the explanted tibial insert we can state that the event is not implant related.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R
• Common Device Name: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9627476
• Report Number: 3005180920-2020-00002
• Device Sequence Number: 379391
• Product Code: JWH
• UDI-Device Identifier: 07630030862380
• UDI-Public: 07630030862380
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2020

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: 04/08/2023
• Device Model Number: 02.12.0023R
• Device Catalogue Number: 02.12.0023R
• Device Lot Number: 179619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 03/17/2020
• 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
• Patient Age: 66 YR
• Patient Weight: 62