LOCK Bipolar Head (REF 5527.09.480)Recalls & reported problems
Limacorporate SPA · Lock bipolar heads (CoCrMo + UHMWPE liner) Dia. 48 for head dia. 28 mm · 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 08033390009768), received between Sep 26, 2024 and Sep 26, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
Patient problems
- Implant Pain1
- Joint Dislocation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
HIP REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO PAIN. ACCORDING TO THE RECEIVED INFORMATION, THE PAIN STARTED AT THE MOMENT THE PATIENT STOOD UP FROM A TOILET. IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL, AND THE X-RAY SHOWED THAT THE IMPLANTED INNER HEAD (FEMORAL MODULAR HEAD - M Ø28MM, PRODUCT CODE 5010.09.282, LOT #1806202 - STER.1800156) DISLOCATED FROM THE LOCK BIPOLAR SELF-CENTERING HEAD Ø48 (PRODUCT CODE 5527.09.480, LOT #1801741 - STER.1800049). DURING THE SURGERY, IMPLANTS WERE REPLACED WITH A BIPOLAR HEAD OF THE SAME SIZE OF THE EXPLANTED ONE AND A COCR HEAD OF SIZE L. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2018. PATIENT IS A FEMALE, 77 YEARS OLD. IT WAS REPORTED SHE'S SEDENTARY. EVENT HAPPENED IN JAPAN.
Patient problems: Implant Pain; Joint Dislocation
MAUDE report 20307679 ↗
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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