MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED HA COATED LAT STEM SIZE 4; UNCEMENTED HIP STEM

Catalog Number	01.18.244
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	11/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 november 2019: lot 133966: 25 items manufactured and released on 28-oct-2013.Expiration date: 2018-09-30.No anomalies found related to the problem.To date, 23 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in complaining of instability which was caused from a loose stem.The cause of the loose stem is unknown.The surgeon revised the stem, head, and liner almost 4 years and 8 months after primary.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM COLLARED HA COATED LAT STEM SIZE 4
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9416216
• Report Number: 3005180920-2019-01043
• Device Sequence Number: 10883704
• Product Code: LZO
• UDI-Device Identifier: 07630030804694
• UDI-Public: 07630030804694
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2019

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: 09/30/2018
• Device Catalogue Number: 01.18.244
• Device Lot Number: 133966
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/05/2019
• 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