Acetabular Instrument Set Beater-Positioner-AlignerRecalls & reported problems
Limacorporate SPA · Beater-Positioner-Aligner · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 08033390025744), received between Aug 1, 2025 and May 21, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (2 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem2
- Difficult to Insert1
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.
MalfunctionMay 21, 2026Mechanical Problem
THE COMPLAINT SOURCE REPORTED AN INTRA-OPERATIVE ISSUE, SINCE IT WAS NOT POSSIBLE TO DISCONNECT BEATER - POSITIONER - ALIGNER (PRODUCT CODE: 9057.20.555, LOT: 20AR0G1) FROM DELTA-TT ACETAB.CUP Ø50 MM ((PRODUCT CODE: 5552.15.500, LOT: 2538423 - STER: (B)(6)) AFTER IMPACTION. AS THERE WAS SUFFICIENT BONE STOCK, THE SOCKET COULD BE REAMED TO THE NEXT ACETABULAR CUP SIZE 52 MM AND SEATED USING THE ALTERNATIVE SETTING INSTRUMENT WRENCH FOR CUPS (PRODUCT CODE:9055.51.015). NO PROLONGED SURGERY WAS REPORTED. THE INSTRUMENT WAS CHECKED PRIOR TO USE. THE INSTRUMENT WAS USED APPROXIMATELY 50 TO 100 TIMES. EVENT OCCURRED IN AUSTRIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238763 ↗MalfunctionAug 1, 2025Difficult to Insert; Mechanical Problem; Difficult to Insert; Mechanical Problem
DURING THE HIP SURGERY PERFORMED ON (B)(6) 2025, THE SURGEON IMPACTED DELTA TT CUP 54 MM (5522.15.540, LOT#2502334) WITH BEATER - POSITIONER - ALIGNER, WHICH WAS ATTACHED TO THE CUP, BUT IT WAS IMPOSSIBLE TO REMOVED IT FROM THE CUP. AGAIN, THE CUP WAS INSERTED, AND IT WAS UNSTABLE. THEREFORE, HE REAMED FOR A CUP (56MM) AND THE CUP WAS IMPLANTED. DUE TO THE EVENT, THE SURGERY WAS PROLONGED FOR 20 MINUTES. BELOW IS THE SUSPECTED PRODUCT: BEATER - POSITIONER - ALIGNER (9057.20.555, LOT#17AP040) - PRODUCT SOLD IN US. EVENT HAPPENED IN JAPAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22686801 ↗
Other Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer devices
- Novation 134-36-45Exactech, Inc. · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2 recalls0 reports
- PINNACLE 1218-28-650Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer89 reports
- Trident 690-00-28FHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall37 reports
- Trident 690-00-22EHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall36 reports
- PINNACLE 1218-32-652Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer75 reports
- Trident 690-00-22DHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall22 reports
- PINNACLE 1218-32-654Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer70 reports
- Trident 69-2850Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall11 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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