MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H 01.18.130 HA COATED STD STEM SIZE 0; HIP CEMENTLESS STEM

Model Number	01.18.130
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 12 june 2020: lot 150839: (b)(4) items manufactured and released on 16-jul-2015.Expiration date: 2020-06-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no other similar reported event.
Event or Problem Description
The patient came in reporting thigh pain after 4 years and 4 months from the primary due to stem loosening (proximally) and potted (distally).The surgeon revised the medacta stem and head with another company's product and revised the medacta liner with a medacta liner.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM H 01.18.130 HA COATED STD STEM SIZE 0
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; CH 6874, CHE
• MDR Report Key: 10217851
• Report Number: 3005180920-2020-00367
• Device Sequence Number: 19360017
• Product Code: LZO
• UDI-Device Identifier: 07630030804069
• UDI-Public: 07630030804069
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2020

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: No Information
• Device Expiration Date: 06/30/2020
• Device Model Number: 01.18.130
• Device Catalogue Number: 01.18.130
• Device Lot Number: 150839
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention