MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE TIBIAL AUGMENTATION SIZE 3/5MM; KNEE TIBIAL AUGMENTATION

Catalog Number	02.09.TA305
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 19 december 2018: lot 145122: (b)(4) items manufactured and released on 17-sep-2014.Expiration date: 2019-07-31.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.Preliminary investigation performed by r&d knee manager: the r&d manager confirmed that an out of label was done and the stability of the construct was not confirmed.Even if the thread is compatible, the screw that was implanted instead of the missing one is not validated for that use.Using the screw ref 75.15.333 contained in the ref.02.07.404fdw instead of the 75.53.0131 (missing in this package) contained in the ref 02.09.Ta305, the fixation of the augment is not guaranteed,.The augment can move in the distal direction.Moreover, the screw protrudes from the plane of the augment, changing the predefined joint line.The surgeon, as confirmed by the agent, had to cement the construct in order to stabilize the wrong screw used.Possible long-term consequences cannot be defined.
Event or Problem Description
Absence of screws in the packaging.The inner package that usually contains the screws was present but no screw was found.The surgeon used the screw present in the wedge ref 02.07.404fdw, lot n°169024 (different from the screw missing) to complete the surgery and cemented the construct.

• Brand Name: GMK-HINGE TIBIAL AUGMENTATION SIZE 3/5MM
• Common Device Name: KNEE TIBIAL AUGMENTATION
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8184343
• Report Number: 3005180920-2018-01017
• Device Sequence Number: 16620076
• Product Code: KRO
• UDI-Device Identifier: 07630030825699
• UDI-Public: 07630030825699
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

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: 07/31/2019
• Device Catalogue Number: 02.09.TA305
• Device Lot Number: 145122
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 12/20/2018
• 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