MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM HA COATED STD STEM SIZE 6; UNCEMENTED HIP STEM

Catalog Number	01.18.136
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 september 2019: lot 160645: (b)(4) items manufactured and released on 09-may-2016.Expiration date: 2021-04-25.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 reviews performed on 10 september 2019: cup: mpact 01.32.160dh acetabular shell ø60 two-holes (k132879) lot 161861: (b)(4) items manufactured and released on 15-sep-2016.Expiration date: 2021-09-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar event reported.Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot 165970: (b)(4) items manufactured and released on 10-jan-2017.Expiration date: 2021-12-19.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.
Event or Problem Description
The patient came in, 2 years and 3 months after primary surgery, complaining of pain, after investigation there was evidence of infection.A revision surgery was performed and all the implants have bee removed.An antibiotic cement was used to lightly cement small implants.

• Brand Name: STEM: AMISTEM HA COATED STD STEM SIZE 6
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9144401
• Report Number: 3005180920-2019-00844
• Device Sequence Number: 19694866
• Product Code: LZO
• UDI-Device Identifier: 07630030804120
• UDI-Public: 07630030804120
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 10/02/2019

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: 04/25/2021
• Device Catalogue Number: 01.18.136
• Device Lot Number: 160645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 10/02/2019
• 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: Hospitalization; Required Intervention
• Patient Weight: 130