MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H COATED STD STEM SIZE 2; HIP UNCEMENTED STEM

Model Number 01.18.132

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Joint Disorder (2373)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 31 july 2020: lot 188410: (b)(4) items manufactured and released on 01-feb-2019.Expiration date: 2024-01-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional devices involved: batch review performed on 31 july 2020: cup: versafitcup cc trio 01.26.45.0052 acetabular shell cc trio ø 52 (k103352) lot 1902309: (b)(4) items manufactured and released on 21-jun-2019.Expiration date: 2024-06-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115).Lot 1900806: (b)(4) items manufactured and released on 08-may-2019.Expiration date: 2024-04-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.The liner involved shell ceramic liner is not marketed in the usa.Clinical evaluation performed by medacta medical affairs director: few months after primary cementless tha, a vast radiolucency is observed all around the femoral stem, which subsided and needs to be removed.The imaging scenario is compatible with deep infection, and this has also been hypothesized by the surgeon.We therefore can surmise that the most likely cause for this adverse event is deep infection.

Event Description

The prosthesis, implanted on (b)(6) 2019, appears slightly subisded radiographically and the patient has been suffering from pain for some time.Revision performed on (b)(6) 2020 (9 months after primary) for suspected infection.For the moment, a spacer has been implanted.The revision was completed successfully.The infection was confirmed the pathogen is (b)(6).

• Brand Name: AMISTEM H COATED STD STEM SIZE 2
• Type of Device: HIP UNCEMENTED 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: 10435816
• MDR Text Key: 203828241
• Report Number: 3005180920-2020-00537
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804083
• UDI-Public: 07630030804083
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K093944
• 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: 08/21/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2024
• Device Model Number: 01.18.132
• Device Catalogue Number: 01.18.132
• Device Lot Number: 188410
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2020
• Initial Date FDA Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2019
• 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
• Patient Age: 68 YR
• Patient Weight: 70