OPRA Implant System 1807Recalls & reported problems
Integrum AB · Fixture BioHelix 19,5x80-12 · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07340152100245), received between Jan 18, 2022 and Jan 18, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Limb Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 18, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ON THE (B)(6) 2021, INTEGRUM RECEIVED AN E-MAIL NOTIFICATION ABOUT A TRAUMA INCIDENT FOR A PATIENT TREATED AT (B)(6) HOSPITAL. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT TRIPPED AND FELL DOWN A FLIGHT OF STAIRS WHICH CAUSED A PERIPROSTHETIC FRACTURE OF THE OPRA IMPLANT. THE FRACTURE IS THROUGH THE TOP OF THE FIXTURE AND THE TREATING SURGEON IS PLANNING A REVISION SURGERY FOR THE PATIENT SHORTLY. IT HAS BEEN REPORTED THAT THE PATIENT IS NOT COMPLIANT WITH THE TREATMENT PROTOCOL, HOWEVER NO INFORMATION HAS BEEN PROVIDED REGARDING IN WHICH WAY THE PATIENT IS NOT COMPLIANT. THE CASE WILL BE FOLLOWED UP ONCE MORE DETAILS ON THE REVISION TREATMENT WITH TREATMENT OUTCOME ARE RECEIVED, AND DEVICE SERIAL AND LOT NUMBERS HAVE BEEN CONFIRMED.
Patient problems: Limb Fracture
MAUDE report 13280321 ↗
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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