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

Catalog Number	02.09.2606R
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 16 march 2018 (b)(4).Visual inspection performed on mar 16, 2018 by cleaning and washing manager: both the outer and the inner blister containing the two involved femoral components received were found cracked during surgery.Moreover, the carton box also shows signs of damage.The third items involved in the case was not returned.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: 1.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.2.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.During the visual inspection, the pictures provided at the moment of the notification were evaluated, too, but they didn't add any further information to the analysis.
Event or Problem Description
When opening the implant, it was noticed that the inner packaging was compromised.The agent had a secondary implant, the packaging was damaged.The surgeon decided to down size to a size 5, the packaging on this implant was also damaged.The agent had the closest sales representative to drive another implant to the hospital.This implant was used to complete the surgery.There was a several hour delay in the case.It was a 10 hours case.The surgery was completed successfully.
Additional Manufacturer Narrative
On mar 29, 2018 the third packaging (lot 155543) was analyzed and it was found less damaged than the other two already received.In detail, it showed only some dents on the inner blister, in correspondence of the area in which the hinge post could accidentally reach the blister inner surface if the package is not handled with caution.All the consideration done for the possible root cause of the other two implants packaging damaged received are confirmed also for this third one.

• 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, 6874 ; SZ 6874
• MDR Report Key: 7345189
• Report Number: 3005180920-2018-00159
• Device Sequence Number: 16339745
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2018

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: 09/30/2018
• Device Catalogue Number: 02.09.2606R
• Device Lot Number: 134930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 04/18/2018
• 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: 59 YR