Delta PF Cup WrenchRecalls & reported problems
Limacorporate SPA · Wrench for Cups · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390025409), received between May 26, 2026 and Jun 11, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2026Mechanical Problem
INTRA-OPERATIVE ISSUE OCCURRED DURING HIP SURGERY ON (B)(6) 2026: TWO OF THE MAGNETS OF THE DELTA CUP - WRENCH (PRODUCT CODE 9055.51.015, LOT 25AR079) CAME LOOSE WHEN THE DELTA CUP WAS DRIVEN INTO THE ACETABULUM. THE COMPLAINT SOURCE REPORTED THAT THE DELTA CUP WAS STILL ABLE TO BE IMPLANTED AND THE SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME. THIS EVENT OCCURRED IN GERMANY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25469771 ↗MalfunctionMay 26, 2026Break
THE DELTA CUP - WRENCH (CODE 9055.51.015, LOT UNKNOWN) BROKE DURING USE: DURING CUP IMPACTION OF CUSTOM-MADE DEVICE 2026-9617-1015, THE END ENGAGED IN THE IMPLANT SHEARED OFF AND COULD NOT BE RETRIEVED FROM WITHIN THE IMPLANT. THE SURGERY WAS COMPLETED WITH NO DELAY, USING ALTERNATIVE IMPACTOR, THE SPACER WAS CORRECTLY SEATED DESPITE THE BROKEN INSTRUMENT TIP. THIS EVENT OCCURRED IN UK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25275495 ↗
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- EXETER 0580-1-351Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous29 reports
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- REFLECTION 71330001Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous20 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.