MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED STD STEM SIZE 3; HIP CEMENTLESS STEM

Model Number	01.18.133
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/17/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed about 6 years and 4 months after the primary surgery due to stem mobilization.Stem was revised with a competitor stem.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023: lot 163095: (b)(4) items manufactured and released on 13-sep-2016.Expiration date: 2021-aug-28.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: AMISTEM H HA COATED STD STEM SIZE 3
• Common Device Name: HIP 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16893762
• Report Number: 3005180920-2023-00346
• Device Sequence Number: 14995906
• Product Code: LZO
• UDI-Device Identifier: 07630030804090
• UDI-Public: 07630030804090
• Combination Product (Y/N): N
• 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: 2023
• 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): 05/09/2023

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: 08/28/2021
• Device Model Number: 01.18.133
• Device Catalogue Number: 01.18.133
• Device Lot Number: 163095
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2016
• 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: Unknown