MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/13 MM RIGHT

Catalog Number	02.12.0213FR
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received on (b)(4) 2017 and includes: revision surgery completed as planned on (b)(6) 2017: the surgeon removed the screw arthroscopically, all remaining components where fine.Short 15 minute operation.The surgeon was very happy with the outcome.The screw only will be available for further investigations.On 30 june 2017 the medical affairs performed a clinical evaluation and commented as follows: loose insert fixation screw 8 months after primary tka.The torque limiting screwdriver was not available at the time of first operation.A possible cause is insufficient tightening torque, but this cannot be demonstrated.No final conclusion can be drawn at this stage.Batch review performed on 19july 2017.Lot 143225: (b)(4) items manufactured and released on 18 september 2014.Expiration date: 2019-08-31.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.
Event or Problem Description
Loose tibial insert screw floating in the knee joint.The surgeon planned to remove screw arthroscopically and assess insert viability, if necessary surgeon will open up and exchange the tibial insert.The surgeon commented that this insert screw was implanted prior to the introduction of the torque limiting screw driver and he feels that he tighten the tibial insert screw tighter now that he has this available.Issue detected during routine follow up x-ray by surgeon.At revision the surgeon removed the screw arthroscopically, all remaining components where fine.The surgeon was very happy with the outcome.
Additional Manufacturer Narrative
The insert screw was reported as available for investigation in the initial report, however the piece was never received by medacta international sa.The complaint has been closed without visual inspection of the item.In case of item return, a follow-up report will be sent to fda.On (b)(6) 2017 it was prepared a final report with the information already submitted in the initial report.On (b)(6) 2017 the report was sent to the initial reporter and the case was closed.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/13 MM RIGHT
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6727740
• Report Number: 3005180920-2017-00393
• Device Sequence Number: 882221
• Product Code: JWH
• UDI-Device Identifier: 07630030862557
• UDI-Public: 07630030862557
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2017

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: 08/31/2019
• Device Catalogue Number: 02.12.0213FR
• Device Lot Number: 143225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 10/06/2017
• 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: 49 YR
• Patient Weight: 85