MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 5; CEMENTLESS HIP STEM

Catalog Number	01.18.145
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 6 august 2019: lot 178460: (b)(4) items manufactured and released on 09-apr-2018.Expiration date: 2023-03-26.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: nine months after cementless total hip arthroplasty, the patient is complaining about pain.Radiographic images provided show the presence of radiolucent areas around the stem suggesting implant loosening and distal fixation.Such an early evolution towards aseptic loosening is unusual and we do not have sufficient information to find an explanation for it.There are no indications that the device has shown any intrinsic defects, but the reason of this event cannot be determined.
Event or Problem Description
Revision surgery planned on (b)(6) 2019 due to pain (10 months after primary surgery), the stem is distally fixed and not in the proximal part, potting.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 5
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8949800
• Report Number: 3005180920-2019-00720
• Device Sequence Number: 2471588
• Product Code: LZO
• UDI-Device Identifier: 07630030804212
• UDI-Public: 07630030804212
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2023
• Device Catalogue Number: 01.18.145
• Device Lot Number: 178460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/30/2019
• 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: Required Intervention
• Patient Weight: 70