MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 LM - 9MM

Catalog Number	02.18.IF4.09.LM
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2017, lot 167800: (b)(4) items manufactured and released on (b)(6) 2017.Expiration date: 12/12/2021 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
During a moto primary case, the implant wouldn't lock into the baseplate even if the surgeon tried for several times.He then put in a trial insert to allow the cement to cure and then opened a secondary implant to complete the surgery.2 minute of delay.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection of the returned tibial insert performed by r&d product manager on (b)(6) 2018: the posterior "clipping" tooth of the insert have been plastically deformed and damaged.It presents a sort of incision with the negative shape of the clipping tooth of the baseplate.We can suppose that probably, in the first attempt to fix the insert into the baseplate, the insert was not posteriorly well positioned or it was not possible to be well positioned due to the presence of a third body (cement) in the baseplate.In this attempt the insert was pushed posteriorly and was permanently damaged without possibility to be clipped in the following attempts.We can state that the event is not implant related.An insert of different batch was successfully implanted later.
Event or Problem Description
During a moto primary case, the implant wouldn't lock into the baseplate even if the surgeon tried for several times.He then put ina trial insert to allow the cement to cure and then opened a secondary implant to complete the surgery.2 minute of delay.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 LM - 9MM
• Common Device Name: TIBIAL INSERT FIX
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7147253
• Report Number: 3005180920-2017-00779
• Device Sequence Number: 16369926
• Product Code: HSX
• UDI-Device Identifier: 07630030896118
• UDI-Public: 07630030896118
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2021
• Device Catalogue Number: 02.18.IF4.09.LM
• Device Lot Number: 167800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 02/01/2018
• 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: 49 YR