MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION EXTENSION STEM - FLUTED Ø 12 L 65; KNEE EXTENSION STEM

Catalog Number	02.07.FCL12065
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation: 3 years after revision tka in a complex case, the screw holding together the offset and the extension stem is visibly loos and out of its seating.Removal of the screw is of course highly recommended.An arthroscopic removal would be advisable but it is probably very difficult due to screw position.It is very likely that no further action is required, i.E.That the offset and stem can be left untouched with no consequences, however this cannot be predicted because we can recall no evidence of former similar situations.For the same reason, we are unable to supply a sound proposal as to the causes of the event.In similar situations, the only situation that we have been able to reproduce in order to obtain spontaneous screw back out was insufficient tightening torque, but we cannot exclude other unknown causes.Batch review performed on 20 september 2019.Lot 142939: 25 items manufactured and released on 10-sep-2014.Expiration date: 2019-07-31.No anomalies found related to the problem.To date, 19 items of the same lot have been already sold without any other similar reported event.Other device involved in the event: gmk-revision 02.07.0003 offset connector 3 mm lot.160317.Batch review performed on 20 september 2019.Lot 160317: 55 items manufactured and released on 04-apr-2016.Expiration date: 2021-03-09.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.
Event or Problem Description
The screw which fixes the offset to the femur is lost (unscrewed), visible at the rx.Revision will be performed (date not planned yet).
Event or Problem Description
The screw which fixes the offset to the femur is lost (unscrewed), visible at the rx.The patient had to undergo to a revision surgery almost 3 months after primary.The surgeon was not able to locate the screw so he left it in the patient, he then replaced the inlay with a bigger one and placed a new screw in the femur with the correct torque limiter screwdriver." the correct primary date to be reported, is (b)(6) 2019.
Additional Manufacturer Narrative
The screw which fixes the offset to the femur is lost (unscrewed), visible at the rx.The patient had to undergo to a revision surgery almost 3 months after primary.The surgeon was not able to locate the screw so he left it in the patient, he then replaced the inlay with a bigger one and placed a new screw in the femur with the correct torque limiter screwdriver." the correct primary date to be reported, is (b)(6) 2019.Clinical evaluation performed by medacta medical affairs director with correct delta time (primary-revision): 3 months after revision tka in a complex case, the screw holding together the offset and the extension stem is visibly loose and out of its seating.Removal of the screw is of course recommended.An arthroscopic removal would be advisable but it is probably very difficult due to screw position.It is very likely that no further action is required, i.E.That the offset and stem can be left untouched with no consequences, however this cannot be predicted because we can recall no evidence of former similar situations.For the same reason, we are unable to supply a sound proposal as to the causes of the event.In similar situations, the only situation that we have been able to reproduce in order to obtain spontaneous screw back out was insufficient tightening torque, but we cannot exclude other unknown causes.

• Brand Name: GMK-REVISION EXTENSION STEM - FLUTED Ø 12 L 65
• Common Device Name: KNEE EXTENSION STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9178277
• Report Number: 3005180920-2019-00855
• Device Sequence Number: 409673
• Product Code: JWH
• UDI-Device Identifier: 07630030822902
• UDI-Public: 07630030822902
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K120790
• 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,Followup
• Report Date (Section B): 12/19/2019

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: 07/31/2019
• Device Catalogue Number: 02.07.FCL12065
• Device Lot Number: 142939
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 09/11/2019; 09/11/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 11/13/2019; 12/19/2019
• 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: Other
• Patient Age: 57 YR