MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM HA COATED STD STEM SIZE 7; HIP CEMENTLESS STEM

Model Number	01.18.137
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 october 2020: lot 180012: (b)(4) items manufactured and released on 08-jun-2018.Expiration date: 2023-05-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional device involved: batch review performed on 02 april 2020: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot 189645: (b)(4) items manufactured and released on 12-feb-2019.Expiration date: 2024-02-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.The liner involved is not marketed in the usa.
Event or Problem Description
Revision surgery performed, 1 year and 5 months after primary surgery, due to pain.The stem was not osseointegrated.No infection found.

• Brand Name: AMISTEM HA COATED STD STEM SIZE 7
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10746076
• Report Number: 3005180920-2020-00755
• Device Sequence Number: 3180301
• Product Code: LZO
• UDI-Device Identifier: 07630030804137
• UDI-Public: 07630030804137
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• 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): 10/28/2020

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: 05/27/2023
• Device Model Number: 01.18.137
• Device Catalogue Number: 01.18.137
• Device Lot Number: 180012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/28/2020
• 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
• Patient Age: 53 YR
• Patient Weight: 88