MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 7; HIP FEMORAL STEM

Catalog Number	01.18.137
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department stem revision performed 4 years and 10 months from the primary tha.After a few years of good outcome the patient lamented onset of pain.The prerevision image shows signs of bone sufferance, whose origins we cannot determine with the information at end.Such signs of periosteal reaction may be due to pathological causes, more seldom to mechanical reasons.The reason of this failure cannot be determined.Visual inspection performed by r&d project manager looking at the stem body an opaque white film is visible on approximately half of the stem length.It is not possible to identify if this film is ha or bone residual, or a combined effect.Absorption of ha from the stem body can indicate that metabolic activity was taking place and that, presumably, adequate bone contact was achieved at the time of surgery.Some signs of minor damage and scratches are present on the neck of the explanted stem, which is likely due to the revision surgery and not relevant to the reported issue.We analyzed the stem dimension comparing with x-ray template 100% scale finding perfect shape correspondence as expectable.Based on the analysis completed and information available, it is not possible to identify a root cause.Batch review performed on 02 november 2023.Lot 154519: 50 items manufactured and released on 28-dec-2015.Expiration date: 2020-12-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
At about 4 years and 10 months from the primary, the patient came in reporting pain.The reason of the pain is unknown.The surgeon revised the stem and the head.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 7
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18203445
• Report Number: 3005180920-2023-00906
• Device Sequence Number: 6255493
• Product Code: LZO
• UDI-Device Identifier: 07630030804137
• UDI-Public: 07630030804137
• 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: 2019
• Device Explanted Year: 2023
• 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): 11/24/2023

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: 12/01/2020
• Device Catalogue Number: 01.18.137
• Device Lot Number: 154519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2015
• 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