MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 6 R

Catalog Number	02.09.2606R
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 05 february 2019: lot 177961: (b)(4) items manufactured and released on 05-jan-2018.Expiration date: 2022-12-11.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.Investigation performed by washing and packaging manager: in the pictures received the inner blister containing the involved femoral components is cracked moreover, the carton box also shows signs of damage.According to internal procedures, the operator involved in the manufacturing process must 100% check the integrity of the whole package of each single item of the lot.Considering that it is implausible for the device to be released with such damage by medacta international (b)(4), the two following root causes could be evaluated: anomalous shipping conditions: considering the extent of the breakage, it can be reasonably excluded that the damage could have been generated by standard shipping methods.Accidental handling damage: it is possible that during handling/storage at the hospital an accidental event occurred resulted in the damage.Considering the points above, the most probable root cause could be found in accidental shipping/ handling damage.Only the implant was received for the investigation (packaging was not returned).From the returned device no visual inspection is possible because the packaging was not received.
Event or Problem Description
During the primary knee surgery, it was discovered that the size 6 femoral component packaging (blister and box) was damaged and the sterility was compromised.There was not another size 6 femoral component available and the surgeon had to use a size 5 instead.This caused an hour and a half delay in the case, anyway the surgery was completed successfully.

• Brand Name: GMK-HINGE FEMORAL COMPONENT SIZE 6 R
• Common Device Name: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8310183
• Report Number: 3005180920-2019-00025
• Device Sequence Number: 11294191
• Product Code: KRO
• UDI-Device Identifier: 07630030825507
• UDI-Public: 07630030825507
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2022
• Device Catalogue Number: 02.09.2606R
• Device Lot Number: 177961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 02/06/2019
• 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