MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 6; CEMENTLESS STEM

Model Number	01.18.146
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 june 2020: lot 110832: (b)(4) items manufactured and released on 13-apr-2011.Expiration date: 2016-03-31.No anomalies found related to the problem.(b)(4) item resterilized and released on 04-feb-2016.Expiration date: 2021-01-24.No anomalies found related to the problem.(b)(4) items resterilized and released on 26-jul-2016.Expiration date: 2021-07-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.
Event or Problem Description
The patient came in reporting pain due to a loose stem.The surgeon revised the medacta stem and head with another company's product and revised the medacta liner with a medacta liner 8 years and 3 months after primary.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 6
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10264554
• Report Number: 3005180920-2020-00406
• Device Sequence Number: 19599562
• Product Code: LZO
• UDI-Device Identifier: 07630030804229
• UDI-Public: 07630030804229
• 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: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

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: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: 01.18.146
• Device Catalogue Number: 01.18.146
• Device Lot Number: 110832
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 07/13/2020
• 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