MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø60 NO-HOLE; HIP UNCEMENTED SHELL

Model Number	01.32.160SH
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
At 3 weeks after the primary surgery, the patient came in reporting pain and stiffness.It was determined from x-rays that the cup had fractured through the anterior/medial wall of the pelvis and the cause is unknown.The surgeon revised the cup, liner and head successfully.The patient's bone was soft.
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 15 october 2021: lot 182581: (b)(4) items manufactured and released on 5-09-2018.Expiration date: 2023-08-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.

• Brand Name: MPACT ACETABULAR SHELL Ø60 NO-HOLE
• Common Device Name: HIP UNCEMENTED SHELL
• 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: 12777448
• Report Number: 3005180920-2021-00875
• Device Sequence Number: 3644125
• Product Code: LPH
• UDI-Device Identifier: 07630030810961
• UDI-Public: 07630030810961
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2023
• Device Model Number: 01.32.160SH
• Device Catalogue Number: 01.32.160SH
• Device Lot Number: 182581
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2018
• 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
• Patient Sex: Male