MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H FEMORAL STEMS; AMISTEM-H STD. SIZE 2

Model Number	01.18.132
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 5 november 2025.Lot 152131: (b)(4) items manufactured and released on 10-aug-2015.Expiration date: 30-jun-2020.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event since the batch release.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
Revision surgery due to hip stem loosening.The specific date of the primary surgery is unknown; it is performed in 2015 or 2018.
Additional Manufacturer Narrative
On 04 february 2026 the device involved in the event returned for analysis.Follow-up: date of return of the device: 04-feb-2026, batch review updated (3-mar-2026), visual inspection, primary surgery date 17 november 2015.Information received on 26 february 2026.Corrected event description.Visual inspection: during the analysis it is evaluated that the explanted stem body does not presents signs of coating residuals.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.One deep sign of surface damage is present on the neck part located in the middle of its radius: taking into account that the cup has been left in place without any complaints it is reasonable to assume that also this sign is related to the revision surgery.Based on the analysis completed and information available, it is not possible to identify a root cause of the stem loosening reported.Batch review performed on 03 march 2026: stem: amistem h 01.18.132 amistem-h std.Size 2 (k093944) lot 152131: (b)(4) items manufactured and released on 16-jul-2015.Expiration date: 30-jun-2020.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with two similar reported event since the batch release (one of these two similar events concerns the same patient, the other side of the hip).Root cause: aseptic loosening is a possible literature-described adverse event after primary joint arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.
Event or Problem Description
At about 9 years and 11 months from primary a revision surgery was performed due to hip stem loosening.The primary surgery was done in germany and was a bilateral surgery, where two stems of the same lot were implanted, one in each femur.Only one side was revised during this revision surgery.

• Brand Name: AMISTEM H FEMORAL STEMS
• Common Device Name: AMISTEM-H STD. SIZE 2
• 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: 23615337
• Report Number: 3005180920-2025-01149
• Device Sequence Number: 8969098
• Product Code: LZO
• UDI-Device Identifier: 07630030804083
• UDI-Public: 07630030804083
• Combination Product (Y/N): N
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: 06/30/2020
• Device Model Number: 01.18.132
• Device Lot Number: 152131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2015
• 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 Age: 58 YR
• Patient Sex: Female