LOCK Bipolar Head (REF 5527.09.470)Recalls & reported problems
Limacorporate SPA · Lock bipolar heads (CoCrMo + UHMWPE liner) Dia. 47 for head dia. 28 mm · Class 2 · Implant
Data updated Oct 16, 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 08033390009751), received between Sep 11, 2024 and Sep 11, 2024 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
HIP REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO PAIN AND DISLOCATION OF THE FEMORAL MODULAR HEAD - M Ø28MM (PRODUCT CODE 5010.09.282, LOT #1704178 - STER. 1700164) FROM THE LOCK BIPOLAR SELF-CENTERING HEAD Ø47 (PRODUCT CODE 5527.09.470, LOT #1700683 - STER. 1700036). IT WAS REPORTED THAT THE PATIENT FELT PAIN WHEN SITTING IN A CHAIR AND LEANING FORWARD. ACCORDING TO THE RECEIVED INFORMATION, THE X-RAY SHOWED THAT THE C-RING WAS DISENGAGED AS THE INNER HEAD APPEARED TO BE DISENGAGED FROM THE LOCK BIPOLAR HEAD. AN ACETABULAR CUP, LINER AND A REVISION FEMORAL HEAD WERE IMPLANTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2017. IT WAS THE PRIMARY SURGERY. PATIENT IS A FEMALE. EVENT HAPPENED IN JAPAN.
Patient problems: Implant Pain
MAUDE report 20190756 ↗
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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