Lock Bipolar Femoral Head 5527.09.490Recalls & reported problems
Limacorporate SPA · Lock Bipolar Femoral Head - Dia.49mm for Heads Dia.28mm · Class 2 · 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 08033390297899), received between Sep 17, 2026 and Sep 17, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Detachment of Device or Device Component
Revision was performed due to dissociation of C-ring for the bipolar cup on (b)(6) 2026. The primary surgery was performed in 2017. The timing of the dissociation was unknown, but the C-ring had disengaged and was found caught around the stem neck. The split portion of the C-ring appeared to be slightly widened and deformed.No significant wear or damage was identified. Furthermore, no remarkable scratches or other abnormalities were observed on the metal liner of the cup or on the surface of the CoCr head. There was also no evidence of metallosis, such as pigment deposition within the joint.After confirming adequate range of motion and suction fit using a trial bipolar cup of the same size, reimplantation was performed using a new bipolar cup of the same size and a revision head of the same size (28 mm, Medium).Although the preoperative and postoperative radiographs from this revision procedure showed no apparent joint space on the affected side, intraoperative assessment with the trial components demonstrated sufficiently smooth mobility and satisfactory suction stability.Product explated:FEM. MODULAR HEAD - M Ø28MM (Code 5010.09.282, lot unknown).LOCK BIPOL.SELF-CENT.HEAD Ø49(Cod
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803164 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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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