MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H 01.18.138 HA COATED STD STEM SIZE 8; HIP HA COATED STD STEM

Model Number	01.18.138
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain due to a loose stem and the cause is unknown.At 7 years and 8 months after the primary surgery, the surgeon revised the stem, head, and liner with competitor components, and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 1 sep 2022.Lot 143636: (b)(4) items manufactured and released on 04-aug-2014.Expiration date: 2019-jun-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs director: revision at 7 years and 8 months after the primary surgery in a male patient due to pain.According to report, the stem was loose.The surgeon revised the stem, head, and liner, and the surgery was completed successfully.From the radiographic image provided, signs of stress shielding are visible, the sem seems to have found stability only in the distal part.It appears that the revised limb is shorter but we cannot tell if this condition is the result of secondary stem subsidence or if it was present after index operation.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.

• Brand Name: STEM: AMISTEM H 01.18.138 HA COATED STD STEM SIZE 8
• Common Device Name: HIP HA COATED STD 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15509010
• Report Number: 3005180920-2022-00731
• Device Sequence Number: 17664906
• Product Code: LZO
• UDI-Device Identifier: 07630030804144
• UDI-Public: 07630030804144
• 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: 2014
• 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): 09/29/2022

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: 06/30/2019
• Device Model Number: 01.18.138
• Device Catalogue Number: 01.18.138
• Device Lot Number: 143636
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2018
• 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