MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 6; CEMENTLESS STEM

Catalog Number	01.18.416
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Dislocation (2374)
Date of Event	10/14/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Batch review performed on 07 november 2019: lot 180748: (b)(4) items manufactured and released on 11-july-2018.Expiration date: 2023-06-27.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.Clinical evaluation performed by medical affairs director: patient reoperated few months after primary tha due to dislocation.Implants were removed.Cement (not medacta) was applied after removal of implants and the patient had pulmonary embolism and passed away.No reason to suspect that the explanted devices had any role in the pulmonary embolism.The reason for reoperation (dislocation of tha with a very large head) should not be sought in a defective implant.Other implant involved in the event, batch review performed on october 23rd, 2019: ball heads: mectacer 01.29.212 biolox delta ceramic ball head 12/14 ø 40 size s - 4 (k112115) lot.189653 lot 189653: (b)(4) items manufactured and released on 11-lug-2018.Expiration date: 2023-06-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported events (infection and dislocation).
Event or Problem Description
About 4 months after primary the surgeon revised the patient hip for a dislocation.Acetabular components from a competitor.When the patient was opened the surgeon noticed an infection and decided to remove all the implants.After adding cement of competitor (no medacta cement used) the patient went through pulmonary embolism and passed away.The surgeon was implanting only competitor implants.

• Brand Name: STEM: AMISTEM P AMISTEM-P 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: 9290196
• Report Number: 3005180920-2019-00928
• Device Sequence Number: 19423729
• Product Code: LZO
• UDI-Device Identifier: 07630040720151
• UDI-Public: 07630040720151
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 11/07/2019

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: 06/27/2023
• Device Catalogue Number: 01.18.416
• Device Lot Number: 180748
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 11/07/2019
• 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: Death; Required Intervention