AMIStem-P 01.18.407Recalls & reported problems
Medacta International SA · AMIStem-P Std. #7 · Class 2 · Implant
All models of AMIStem-P (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630040720069), received between Feb 8, 2019 and Sep 6, 2024 — classified as 5 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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
- Adverse Event Without Identified Device or Use Problem3
- Device Appears to Trigger Rejection1
- Fracture1
Patient problems
- Bone Fracture(s)2
- Medical device site infection2
- Bacterial Infection1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 6, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT 3 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection; Unspecified Infection
MAUDE report 20154724 ↗InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY PERFORMED ABOUT 5 MONTHS AFTER THE PRIMARY SURGERY DUE TO INFECTION. REVISION COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 18966935 ↗InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem
THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN HAS BEEN IDENTIFIED AS STAPH AUREUS. 1 MONTH AFTER THE PRIMARY THE SURGEON REVISED ALL IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bacterial Infection
MAUDE report 12058169 ↗InjuryMar 11, 2019Fracture
RIGHT AFTER THE PRIMARY SURGERY THE PATIENT CONTINUED TO COMPLAIN OF PAIN. THE SURGEON PERFORMED A POST OP X-RAY AND FOUND THAT THE FEMUR WAS FRACTURED. THE SURGEON THEN, ON THE SAME DAY, PERFORMED A REVISION TO REPLACE THE HEAD, STEM AND THEN CABLED THE FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 8408124 ↗InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem
BONE FRACTURE OCCURRED DURING STEM IMPLANTATION, IT WAS BROACHED TO A AMIS 7 AND IMPLANTED A COLLARLESS 7 AMISTEM-P. THE SURGEON CABLED THE FRACTURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 8319912 ↗
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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