AMIStem-P 01.18.411Recalls & reported problems
Medacta International SA · AMIStem-P Lat. #1 · Class 2 · Implant
All models of AMIStem-P (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040720106), received between Dec 20, 2020 and Apr 3, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Osseointegration Problem1
Patient problems
- Aseptic loosening1
- Inadequate Osseointegration1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2026Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY DUE TO STEM LOOSENING ABOUT 2 YEARS AND 4 MONTHS AFTER PRIMARY SURGERY.
Patient problems: Aseptic loosening
MAUDE report 24776967 ↗InjuryJul 1, 2024Osseointegration Problem; Osseointegration Problem
AT 5 DAYS FROM THE PRIMARY, THE PATIENT HEARD A POP AND FELT PAIN AFTER ATTENDING A PHYSICAL THERAPY SESSION DURING EXERCISES THAT INVOLVED WALKING UP STEPS. WHEN THE SURGEON TOOK X-RAYS, THERE WAS NO EVIDENCE OF A FRACTURE BUT THE PATIENT FELT PAIN, SO THE SURGEON DECIDED TO REVISE. DURING THE SURGERY, THE SURGEON FOUND THE STEM A LITTLE BE LOOSE, SO HE REVISED IT WITH A LONGER ONE AND REVISED THE HEAD TOO. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 19642083 ↗InjuryDec 20, 2020Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN REPORTING PAIN 1 YEAR AND 3 MONTHS AFTER THE PRIMARY. THE POST-OP X-RAYS INDICATED THAT THE STEM HAD TOO MUCH OFFSET. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE CUP WAS REVISED RATHER THAN THE STEM AS IT WAS EASIER TO REVISE. THE CUP WAS MEDIALIZED TO REDUCE THE OFFSET.
Patient problems: Insufficient Information
MAUDE report 11043169 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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