MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED STD SIZE 9; HIP CEMENTLESS STEM

Model Number	01.39.009
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During the primary hip surgery, when the surgeon was implanting the stem, a femoral bone fracture occurred.The surgeon cabled the fracture and upsized the stem to complete the case.There was a 30-minute delay and the surgery was completed successfully.During the same surgery, the surgeon wanted to use two stem repositioners to extract the stem.This is because the femoral bone fracture occurred throughout the implantation of size 9 masterloc std offset stem.The two repositioners slip off the taper of the stem many times, so an alternative medacta extraction device was used.The surgeon cabled the fracture and implanted a size 10 masterloc std offset stem to complete the case.There was a 30-minute delay and the surgery was completed successfully.
Additional Manufacturer Narrative
In the same surgery bone fracture and 2 instruments break during the attempt to remove the stem from the femur.Batch review performed on 27-may-2022: lot 170626: 13 items manufactured and released on 06-jul-2017.Expiration date: 2022-jun-27.No anomalies found related to the problem.To date, 11 items of the same lot have been sold with no similar reported event during the period of the review.Instruments invovled in the case batch review performed on 30-may-2022: masterloc 01.10.10.190 stem repositioner lot 1552968: 103 items manufactured and released on 07-apr-2016.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of the review.Masterloc 01.10.10.190 stem repositioner lot 1653992: 100 items manufactured and released on 17-mar-2017 and 54 items manufactured and released on 7-feb-2017.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of the review.
Additional Manufacturer Narrative
On august 19th 2022 we have received the stem repositioners back.Visual inspection performed by r&d project manager: during the analysis both the stem repositioners were evaluated.One part the blue plastic calmps internal surface was scratched and signed, it seems that is was used in a lot of surgeries.The step that allows the fixation with the stem taper is almost completely consumed, and this should be the cause of the slipping of the stem during the extraction phase (masterloc size 9std) on the second part no sing or scratches are present, it is not possible to determine the root cause of slipping of the stem (masterloc size 9std) during extraction.Unfortunatly the stem masterloc size 9 std (not implanted due to bone fracture) is not available for the visual inspection and check of the taper, so no further assumptions can be added to this analysis.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED STD SIZE 9
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14684862
• Report Number: 3005180920-2022-00456
• Device Sequence Number: 4818290
• Product Code: LZO
• UDI-Device Identifier: 07630030885587
• UDI-Public: 07630030885587
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/27/2022
• Device Model Number: 01.39.009
• Device Catalogue Number: 01.39.009
• Device Lot Number: 170626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2017
• 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: Required Intervention; Other
• Patient Sex: Male