MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED STEM HA COATED STD STEM SIZE 3; HIP CEMENTLESS STEM

Catalog Number	01.18.233
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation: partial hip revision surgery (stem and head) performed 1 year after cementless total hip arthroplasty in a young probably very active man (37 year old).Radiographic images provided show the presence of radiolucent lines in the proximal gruen zones and signs of stress shielding.Aseptic loosening is a possible literature described adverse event cementless thr and causes are often unknown.The reason of this event cannot be determined.Preliminary investigation: explants covered in body fluids.It is not possible to determine an implant-related failure root cause.Batch review performed on 13 september 2019: lot 180040: 75 items manufactured and released on 30-may-2018.Expiration date: 2023-05-21.No anomalies found related to the problem.To date, 72 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery performed after 1 year and 1 month after the primary due to pain.After examining x-ray, the surgeon determined it was most likely a loose stem so he decided to revise.The stem and the head have been revised.The stem may have had micro movement but was still fixed firmly distally and it was removed with great difficulty.

• Brand Name: STEM: AMISTEM COLLARED STEM HA COATED STD STEM SIZE 3
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9171455
• Report Number: 3005180920-2019-00849
• Device Sequence Number: 16657769
• Product Code: LZO
• UDI-Device Identifier: 07630030804588
• UDI-Public: 07630030804588
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 10/09/2019

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: 05/21/2023
• Device Catalogue Number: 01.18.233
• Device Lot Number: 180040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 10/09/2019
• 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 Age: 37 YR
• Patient Weight: 70