MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H 01.18.134 HA COATED STD STEM SIZE 4; HIP STEM CEMENTLESS

Model Number	01.18.134
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	06/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27-jun-2023.Lot: 156859: (b)(4) items manufactured and released on 17-mar-2016.Expiration date: 2021-03-03.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.Analysis performed by r&d manager: looking at the images attached to the complaint it seems that no ha residuals are present on the stem body.The explanted stem is covered by patient blood.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 but the x-rays are not available.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
Revision surgery at about 7 years 1 month after the primary due to stress shielding and proximal stem loosening.The surgery has been completed successfully by using a quadra h.

• Brand Name: STEM: AMISTEM H 01.18.134 HA COATED STD STEM SIZE 4
• Common Device Name: HIP STEM CEMENTLESS
• 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: 17361808
• Report Number: 3005180920-2023-00533
• Device Sequence Number: 6041489
• Product Code: LZO
• UDI-Device Identifier: 07630030804106
• UDI-Public: 07630030804106
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 07/20/2023

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: 03/03/2021
• Device Model Number: 01.18.134
• Device Catalogue Number: 01.18.134
• Device Lot Number: 156859
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2016
• 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