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

Catalog Number 02.09.2606R

Device Problems Tear, Rip or Hole in Device Packaging (2385); Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2019

Event Type  malfunction  

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 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
• Type of Device: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8310183
• MDR Text Key: 137547452
• Report Number: 3005180920-2019-00025
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this a Product Problem Report?: Yes

Device Operator

• 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

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/06/2019 Patient Sequence Number: 1