A.L.P.S.® 8513-18-601Recalls & 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 00887868436048), received between Jan 8, 2026 and Jan 8, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Loosening of Implant Not Related to Bone-Ingrowth1
- Migration1
Patient problems
- Aseptic loosening1
- Skin Discoloration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2026Loosening of Implant Not Related to Bone-Ingrowth; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF THE ALPS ELBOW PLATE AND SCREWS APPROXIMATELY FOUR (4) MONTHS POST-IMPLANTATION AFTER IT WAS DISCOVERED THAT TWO DISTAL SCREWS HAD COME LOOSE AND BACKED OUT. THE AFFECTED AREA ALSO SHOWED SIGNS OF PIGMENTATION. PATIENT'S REHABILITATION PROTOCOL INDICATED THE PAIN IS SUBSIDING, WHILE THEY ARE ALSO UNDERGOING MUSCLE STRENGTHENING EXERCISING AND RANGE OF MOTION EXERCISES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Skin Discoloration
MAUDE report 24009758 ↗
Other WASHER, BOLT NUT devices
- FIBULINK FGS-1000Synthes GmbH · Washer, Bolt Nut117 reports
- Arthrex® AR-2372BLOArthrex, Inc. · WASHER, BOLT NUT91 reports
- Arthrex® AR-8925SSArthrex, Inc. · WASHER, BOLT NUT79 reports
- Arthrex® AR-8925TArthrex, Inc. · WASHER, BOLT NUT71 reports
- Arthrex® AR-8926TArthrex, Inc. · WASHER, BOLT NUT61 reports
- RipCord STA001KTrimed, INC. · WASHER, BOLT NUT1 recall2 reports
- Arthrex® AR-7000-18TArthrex, Inc. · WASHER, BOLT NUT1 recall0 reports
- Arthrex® AR-8926SSArthrex, Inc. · WASHER, BOLT NUT35 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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