MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-C CEMENTED, MIRROR POLISHING STEM SIZE 5 12/14 STD; CEMENTED FEMORAL STEM

Catalog Number	01.12.045
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 11 july 2017 the cleaning and packaging manager performed a visual inspection of the retrieved item and commented as follows: considering the implant that was not in a correct position, it is probable that during the transportation or implant storage the distal foam slightly disassembled from the implant broke the plastic packaging due to the nature of the stem and because it was free to move.The displacement possibly occurred due to forces experienced during transportation.The packaging configuration allow more degrees of freedom for movement within the package.Reportedly, it seems that the tyvek was easy to be opened and not well fixed all around.Looking at the pictures received from the branch it is clearly visible the presence of the glue at the edges of the blister, this means that the welding process was correctly performed.The machine welding process is standard and validated, furthermore, a welding control is performed by the operator for each implant.Based on the information received and given that we only received back the implant, without the blister and the tyvek, it is not possible to establish a certain root cause for the event reported.Batch review performed on 11 july 2017.Lot 166241: (b)(4) items manufactured and released on 28 november 2016.Expiration date : 2021-11-15.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.
Event or Problem Description
When the nurse opened the blister, the cover paper was not well stuck all around, there was no resistance by opening the box, and the implant was not in place anymore.As the surgeon was not sure about the sterility of the implant, he decided to not implant the item and to open another one.

• Brand Name: QUADRA-C CEMENTED, MIRROR POLISHING STEM SIZE 5 12/14 STD
• Common Device Name: CEMENTED FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6714009
• Report Number: 3005180920-2017-00376
• Device Sequence Number: 10810098
• Product Code: LZO
• UDI-Device Identifier: 07630030802263
• UDI-Public: 07630030802263
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083558
• 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
• Report Date (Section B): 07/14/2017

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: 11/15/2021
• Device Catalogue Number: 01.12.045
• Device Lot Number: 166241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 07/14/2017
• 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