MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H COLLARED FEMORAL STEMS; AMISTEM COLLARED HA COATED STEM SIZE 4 STD

Model Number	01.18.234
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 july 2026 lot: 173444: (b)(4) items manufactured and released on 31 oct 2017.Expiration date: 18 oct 2022.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.Root cause: aseptic loosening is a possible literature-described adverse event after primary hip 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.
Event or Problem Description
Revision surgery due to stem loosening after about 7 years and 6 months from primary.The surgeon revised the amistem h collared standard size 4 to a monoblock stem d 13mm l 190mm std, revised the 36mm biolox delta head m to a 40mm biolox option head with sleeve, and revised the hooded pe hc liner d 36/f to a flat pe hc liner d 40/f at his discretion.Xrays are unavailable.

• Brand Name: AMISTEM H COLLARED FEMORAL STEMS
• Common Device Name: AMISTEM COLLARED HA COATED STEM SIZE 4 STD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25778117
• Report Number: 3005180920-2026-00688
• Device Sequence Number: 10686877
• Product Code: LZO
• UDI-Device Identifier: 07630030804595
• UDI-Public: 07630030804595
• Combination Product (Y/N): N
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2026

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: 10/18/2022
• Device Model Number: 01.18.234
• Device Lot Number: 173444
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2017
• 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