MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR SIZE 3 STD LEFT; KNEE FEMORAL COMPONENT CEMENTED

Catalog Number	02.07.2503L
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information received on 19 june 2017 and includes: the surgery was a primary and the posterior cruciate ligament was cut in order to use a different implant.On 20 june 2017 the cleaning and packaging manager performed a preliminary investigation and commented as follows: as clearly visible in the picture, the gmk-revision std femur (reference 02.07.2503l and lot.157861) has a posterior cam while it should be only present in the gmk-revision ps femur.The initial casting is the same for gmk-revision std and ps femurs.An external supplier was responsible for cutting the cam since the product was a standard femur.Due to an involuntary human error the cam was not cut.Also, during the subsequent activities no one detected the discrepancy, the ps femur was shipped as it was std.As confirmed by the supplier, only the four pieces of the lot 157861 were incorrect.No recall has been performed given that the 3 remained implants, of the same lot, were not in consignment in any hospital but they were under control in different medacta warehouse.They were immediately quarantined by medacta.Batch review performed on 06 july 2017.Lot 157861: (b)(4) items manufactured and released on 26 february 2016.Expiration date: 2021-01-20.No anomalies found in the batch review.Specifically, the cut of the stabilized cam is indicated as performed.
Event or Problem Description
A ps gmk-revision femur was found in the packaging instead of a std gmk-revision femur.The surgeon had to switch from the planned std femur with a stem, a mobile tibiaplateau and a mobile std insert, to a ps femur with a fixed tibiaplateau, a stem and a semiconstrained inlay.The wrong femur was implanted.The surgery was successfully.No x-rays available.
Additional Manufacturer Narrative
On (b)(6) 2017 the following actions have been communicated from medacta side: addition of the control of the presence of the ps stabilizer at laser marking step.Specification about the control of the presence of the ps stabilizer at the packaging step, where a visual control was foreseen but without that specific detail clearly indicated.Also the external supplier involved in the problem has implemented corrective actions in his steps in order to avoid similar issues in the future.

• Brand Name: GMK-REVISION FEMUR SIZE 3 STD LEFT
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6692851
• Report Number: 3005180920-2017-00358
• Device Sequence Number: 1761252
• Product Code: JWH
• UDI-Device Identifier: 07630030821523
• UDI-Public: 07630030821523
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2017

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: 01/20/2021
• Device Catalogue Number: 02.07.2503L
• Device Lot Number: 157861
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 08/03/2017
• 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: Other