MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM; FIXED TIBIAL INSERT

Model Number	02.07.0310PSF
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 july 2020: lot 124608: (b)(4) items manufactured and released on 07 february 2013.Expiration date: 2017-12-31.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event since 2016.Clinical evaluation performed by medical affairs director: more than 7 years after primary total knee arthroplasty, the insert fixation screw got loose in the joint.The cause for self-unscrewing of the insert screw is not known: one possibility is insufficient tightening torque, but other unknown conditions may also play a role.Preliminary investigation performed by r&d project manager: revision surgery of a gmk primary ps knee due to pain after 7 years from primary surgery.Xrays shown that the insert secure screw baked out and was loosened in the joint.Looking at the picture of the explanted inlay, any anomalies related to the event can't be identified.The insert looks regularly worn out considering the 7 years of usage; some scratches are present in the articular surface most likely caused during the attempt to explant the component.No other components have been removed, so we can suppose that they have been found in good condition during revision surgery to remove the screw and the insert.The most likely cause for self-unscrewing of the screw is insufficient tightening torque.But other unknown / unpredictable causes may also play a role that has not been reproduced in laboratory this far.Torque limiting screwdriver, currently mandatory to lock the insert secure screw, was not used during the primary surgery.
Event or Problem Description
Revision surgery performed 7 years and 2 months after the primary surgery due to inlay locking screw unscrewing.The liner was replaced.
Additional Manufacturer Narrative
Device returned on 14-sep-2020 and analyzed on 18-sep-2020.Also, on 22-sep-2020, clinical evaluation has been updated.Visual inspection performed by r&d project manager.From visual inspection, we can confirm what already stated in the preliminary investigation.No anomalies can be identified that could be relevant for the event.The insert looks regularly worn considering the 7 years of usage; some dents and scratches are present in the articular surface and on the ps cam that were most likely caused during the attempt to explant the component.No other components have been removed, so we can suppose that they have been found in good condition during revision surgery to remove the screw and the insert.The most likely cause for self-unscrewing of the screw is insufficient tightening torque but other unknown/unpredictable causes may also play a role that has not been reproduced in the laboratory this far.Clinical evaluation performed by medical affairs director.More than 7 years after primary total knee arthroplasty, the insert fixation screw got loose in the joint.The cause for self-unscrewing of the insert screw is not known: one possibility is insufficient tightening torque, but it is also possible that an unpredictable and undescribed event intervened shortly before unscrewing and triggered the event.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10229313
• Report Number: 3005180920-2020-00380
• Device Sequence Number: 573297
• Product Code: JWH
• UDI-Device Identifier: 07630030817069
• UDI-Public: 07630030817069
• 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: 2013
• 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,Followup
• Report Date (Section B): 10/14/2020

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: 12/31/2017
• Device Model Number: 02.07.0310PSF
• Device Catalogue Number: 02.07.0310PSF
• Device Lot Number: 124608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 10/14/2020
• 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: 104