OPRA Implant System IBC0012Recalls & reported problems
Integrum AB · Fixture 18x80 · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07340152100443), received between Feb 6, 2020 and Jul 1, 2020 — classified as 2 injuries.
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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Unspecified Infection2
- Bacterial Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(6) 2020: INTEGRUM RECEIVED INFORMATION REGARDING FIXTURE REMOVAL SURGERY TO BE PERFORMED IN THE END OF(B)(6). SURGERY PERFORMED (B)(6) 2020. IT WAS REPORTED THAT: FIXTURE WAS WELL INTEGRATED AND THAT THE SURGEON DOES NOT THINK THE IMPLANT SYSTEM WAS THE CAUSE OF THE INFECTION RATHER THE PRE OPERATIVE OI HISTORY WHICH HAD SOME ISSUES - REMOVAL OF BONE CEMENT IN PREPARATION FOR OI BACK IN 2009. NO OTHER INFORMATION OBTAINED. (B)(6) 2020: BATCH DOCUMENTATION REVIEWED, NO DEVIATIONS FOUND.
Patient problems: Bacterial Infection; Unspecified Infection
MAUDE report 10217161 ↗InjuryFeb 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
9TH OF JANUARY 2020 INTEGRUM RECEIVED INFORMATION THAT PATIENT WILL REMOVE FIXTURE DUE TO FIXTURE LOOSENING. PATIENT HAS HAD A HISTORY OF INFECTIONS AND PAIN. INFECTION WILL BE TREATED BY DEBRIDEMENT, LOCAL AND SYSTEMIC ANTIBIOTICS. BATCH DOCUMENTATION REVIEWED. NO DEVIATIONS FOUND IN PRODUCT. PATIENT HAD THE IMPLANT FOR 14 YEARS AND THEREFORE THIS IS NOT CONSIDERED AN EARLY FAILURE. 4T OG (B)(6) 2020 FIXTURE REMOVAL SURGERY PERFORMED. FIXTURE WILL NOT BE REPLACED. NO FURTHER INFORMATION WILL BE OBTAINED.
Patient problems: Unspecified Infection
MAUDE report 9678162 ↗
Other Transfemoral Percutaneous Prosthetic devices
- OPRA Implant System 1288Integrum AB · Transfemoral Percutaneous Prosthetic109 reports
- OPRA Implant System 1820Integrum AB · Transfemoral Percutaneous Prosthetic8 reports
- OPRA Implant System 1804Integrum AB · Transfemoral Percutaneous Prosthetic4 reports
- OPRA Implant System 1800Integrum AB · Transfemoral Percutaneous Prosthetic4 reports
- OPRA Implant System 1808Integrum AB · Transfemoral Percutaneous Prosthetic3 reports
- OPRA Implant System 1803Integrum AB · Transfemoral Percutaneous Prosthetic2 reports
- OPRA Implant System 1811Integrum AB · Transfemoral Percutaneous Prosthetic2 reports
- OPRA Implant System 1810Integrum AB · Transfemoral Percutaneous Prosthetic2 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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