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

Catalog Number	01.18.142
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24-may-2024 lot 174369: (b)(4) items manufactured and released on 13-dec-2017.Expiration date: 2022-11-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department: revision about 5 years and 7 months after primary tha due to stem loosening.It is reported that no infection is present.Radiographic images provided show slightly shortened leg, or perhaps subsidence of the stem secondary to loosening and the stem looks slightly undersized.The reason of this choice cannot be assessed.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.
Event or Problem Description
At about 5 years and 7 months after primary, the patient has been revised because of stem proximal loosening.No infection detected.The stem was removed very easily and it looked undersized.A competitor device has been successfully implanted.
Additional Manufacturer Narrative
Visual inspection performed by r&d 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.The post-op x-ray analysis could possibly provide more insight, such as the evaluation of possible early rotational instability or initial stress-shielding.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.Based on the analysis completed and information available, it is not possible to identify a root cause of the stem loosening reported.
Event or Problem Description
At about 5 years and 7 months after primary, the patient has been revised because of stem proximal loosening.No infection detected.All the components have been revised successfully.The stem was removed very easily and it looked undersized.Competitor devices have been successfully implanted.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 2
• Common Device Name: HIP 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: 19389770
• Report Number: 3005180920-2024-00330
• Device Sequence Number: 15192434
• Product Code: LZO
• UDI-Device Identifier: 07630030804182
• UDI-Public: 07630030804182
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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: 11/30/2022
• Device Catalogue Number: 01.18.142
• Device Lot Number: 174369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2017
• 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: Unknown