MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 12; HIP CEMENTLESS STEM

Catalog Number	01.39.012
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 20 october 2023: lot 1902835: 8 items manufactured and released on 17-jul-2019.Expiration date: 2024-jul-07.No anomalies found related to the problem.To date, 2 items of the same lot have been sold with no similar reported event during the period of review.Preliminary investigation performed by washing & packaging manager: the package was broken presumably due to an accidental fall.From the photo received, the distal blisters that are used to hold the piece inside and prevent it from moving are not visible, however, in our system they appear to be used and so we expect they were inserted inside the packaging.
Event or Problem Description
During the primary hip surgery, when the agent opened up the stem implant, it was observed that the implant had broken through the sterile packaging and the cause is unknown.The issue was noted when the femoral bone was already prepared.The surgeon decided to re-sterilize it because no back-up was available and they could not go down or up in size.The piece was re-sterilized with steam sterilization.The issue caused 45-minute delay.The surgery was completed successfully; additional anesthesia was administered.Only one blocker was inside the packaging.
Additional Manufacturer Narrative
On 30 jan 2024 we have received the item involved in the event.Visual inspection performed by washing and packaging manager only one distal foam is present inside the packaging, the one that holds the tip and prevents it from moving, while the second foam (the one that holds the stem neck) is not inside.In our system, both are specified and we expect they were inserted inside the packaging.The package was broken presumably due to an accidental fall.

• Brand Name: MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 12
• Common Device Name: HIP CEMENTLESS STEM
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18139035
• Report Number: 3005180920-2023-00875
• Device Sequence Number: 12758098
• Product Code: LZO
• UDI-Device Identifier: 07630030885617
• UDI-Public: 07630030885617
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

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: 07/07/2024
• Device Catalogue Number: 01.39.012
• Device Lot Number: 1902835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: White