MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H 01.18.134 HA COATED STD STEM SIZE 4; HIP COATED STD STEM

Model Number	01.18.134
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 april 2022.Lot 155229: (b)(4) items manufactured and released on 28-dec-2015.Expiration date: 2020-12-13.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2018.Clinical evaluation performed by medical affairs manager: 6 years after primary tha the patient reported pain.We do not have a radiographic history of the case, but the last pre-revision radiograph shows signs of stress-shielding and evident distal cortical thickening.No information concerning patient general health status and the presence of comorbidities is available.The causes for this unfavourable, long term evolution cannot be determined.No reason to suspect that this event is due to a faulty device.
Event or Problem Description
The patient came in reporting pain due to a distally potted stem and the cause is unknown.The surgeon revised the stem, head, and liner 6 years after primary.The surgery was completed successfully.

• Brand Name: AMISTEM H 01.18.134 HA COATED STD STEM SIZE 4
• Common Device Name: HIP COATED STD 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: 14488553
• Report Number: 3005180920-2022-00393
• Device Sequence Number: 17476795
• Product Code: LZO
• UDI-Device Identifier: 07630030804106
• UDI-Public: 07630030804106
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/13/2020
• Device Model Number: 01.18.134
• Device Catalogue Number: 01.18.134
• Device Lot Number: 155229
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/28/2015
• 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