MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 1; CEMENTLESS STEM

Model Number	01.18.131
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 6 years and 2 months after the primary surgery, the patient came in reporting pain due to a loose stem and the cause of the loose stem is unknown.The surgeon revised the stem with a competitor stem and revised the head with a medacta head.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 25-oct-2022: lot 155648: (b)(4) items manufactured and released on 23-dec-2015.Expiration date: 2020-12-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of review.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 1
• Common Device Name: 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15698285
• Report Number: 3005180920-2022-00827
• Device Sequence Number: 5578484
• Product Code: LZO
• UDI-Device Identifier: 07630030804076
• UDI-Public: 07630030804076
• 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): 10/31/2022

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: 12/12/2020
• Device Model Number: 01.18.131
• Device Catalogue Number: 01.18.131
• Device Lot Number: 155648
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2015
• 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: Female