MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-P STD SIZE 3; UNCEMENTED HIP STEM

Catalog Number 01.18.403

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 10/01/2019

Event Type  Death  

Manufacturer Narrative

Batch review performed on (b)(6) 2019: lot 1901563: (b)(4) items manufactured and released on 10 may 2019.Expiration date: 2024-04-30.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 devices involved.Batch reviews performed on (b)(6) 2019: cup: versafitcup 01.26.56mb acetabular shell cc ø 56 (k083116), lot 1901405: (b)(4) items manufactured and released on 14 june 2019.Expiration date: 2024-05-29.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.Liner: versafitcup dm 01.26.2856mhc double mobility hc liner ø 56/28 (k092265), lot 1901458: (b)(4) items manufactured and released on 18 may 2019.Expiration date: 2024-04-30.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.Ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115), lot 1901932: (b)(4) items manufactured and released on 17 june 2019.Expiration date: 2024-05-27.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.

Event Description

The patient had a primary hip surgery on (b)(6) 2019.When the final implants were in, and the surgeon was closing his incision, the patient's heart rate dropped and required resuscitation efforts.The patient was not able to be resuscitated (passed away).There was no indication that the implanted devices led to this event.During this case have been used non cemented implants.

• Brand Name: STEM: AMISTEM-P STD SIZE 3
• Type of Device: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 9254770
• MDR Text Key: 164263962
• Report Number: 3005180920-2019-00914
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630040720021
• UDI-Public: 07630040720021
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/30/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 01.18.403
• Device Lot Number: 1901563
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention