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Plasmacup® NH156TRecalls & reported problems

Aesculap AG · PLASMACUP MSC SIZE 56MM · 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 04038653206193), received between Mar 18, 2022 and Mar 18, 2022 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Appears to Trigger Rejection1

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.

  • InjuryMar 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    IT WAS REPORTED TO AESCULAP AG THAT A PLASMACUP MSC SIZE 56MM (PART # NH156T) WAS IMPLANTED DURING A TOTAL HIP ARTHROPLASTY (THA) PROCEDURE PERFORMED ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, THE PATIENT FELL POSTOPERATIVELY AND UNDERWENT A REVISION OF THE "CUP SIDE". AT THE TIME OF THE REVISION, THE SURGEON NOTED THAT OSTEOLYSIS MAY HAVE OCCURRED; METALLOSIS WAS ALSO POSSIBLE. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT DID NOT HAVE AN INFECTION. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: ISODUR PROSTHESIS HEAD 8/10 28MM L - NJ133K, BATCH 51475043. SC/MSC PE-INSERT 28MM 56/58 SYM.- NH194, BATCH 51408848. PLASMACUP FIXATION SCREW 6.5X20MM - NA770T, BATCH 51493457. PLASMACUP FIXATION SCREW 6.5X20MM - NA770T, BATCH 51501131.

    Patient problems: Failure of Implant

    MAUDE report 13805993 ↗

Other Prosthesis, hip, semi-constrained, metal/polymer, uncemented devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.