Isodur® NJ133KRecalls & reported problems
Aesculap AG · ISODUR PROSTHESIS HEAD 8/10 28MM L · Class 2 · Implant
- 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 04038653117932), received between Dec 6, 2021 and Dec 6, 2021 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED TO AESCULAP AG THAT A ISODUR PROSTHESIS HEAD 8/10 28MM L (PART # NJ133K) WAS IMPLANTED DURING A PRIMARY TOTAL HIP ARTHROPLASTY (THA) PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE IMPLANT DISLOCATED AND THE REVISION SURGERY WAS TEN (10) YEARS FOUR (4) MONTHS POST SURGERY. THE PATIENT WAS EXPECTED TO UNDERGO A REVISION PROCEDURE ON (B)(6) 2021. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION SURGERY WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: NA766T - PLASMACUP FIXATION SCREW, 6.5X16MM - LOT 51726335; NC450T - PLASMACUP SC PLASMAPORE-CAP, SIZE 50MM - LOT 51738636; NH472 - SC/MSC PE-INSERT, 28MM 48/50 ASYM. - LOT 51491493.
Patient problems: Failure of Implant
MAUDE report 12940874 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.