RIM-LOC HIP SYSTEM 105425Recalls & reported problems
Biomet Orthopedics, LLC · 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 00880304191662), received between Feb 17, 2023 and Feb 17, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K030055, K950761); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
- Joint Dislocation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
UPON REASSESSMENT OF THE ADDITIONAL INFORMATION, IT WAS FOUND THAT THIS DEVICE DID NOT CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: Insufficient Information; Joint Dislocation
MAUDE report 16395253 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K030055, K950761. One submission often covers many models, so check the product and lot details in each record.
- Z-0523-2020 · Aug 21, 2019 · TerminatedVarious Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103205 21-103206 21-103207 21-1
- Z-1754-2015 · Apr 16, 2015 · TerminatedMallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral
- Z-1122-2015 · Jan 9, 2015 · TerminatedMallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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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