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

Model Number	01.18.135
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 7 years and 2 months after the primary surgery, the patient came in reporting pain due to a loose stem and the cause is unknown.The surgeon revised the medacta head and stem with competitor components and revised the medacta liner with a medacta liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 08-jun-2022.Lot 146855: (b)(4) items manufactured and released on 10-feb-2015.Expiration date: 2019-12-31.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported case during the period of review.Clinical evaluation performed by medical affairs department.Revision performed 7 years after cementless total hip arthroplasty due to pain.No information regarding the age, the activity level and presence of commodities is provided.Radiographic image provided show the presence of radiolucent lines in gruen zones 1 and 7 and a distally fixed stem which may be the cause of pain.Aseptic loosening is a possible literature described adverse event after cementless hip arthroplasties and causes are often unknown.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 5
• Common Device Name: HIP STEM CEMENTLESS
• 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: 14929583
• Report Number: 3005180920-2022-00505
• Device Sequence Number: 19325299
• Product Code: LZO
• UDI-Device Identifier: 07630030804113
• UDI-Public: 07630030804113
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2022

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: 12/31/2019
• Device Model Number: 01.18.135
• Device Catalogue Number: 01.18.135
• Device Lot Number: 146855
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male