A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEMHIGH PLATE LEFTRecalls & reported problems across all models

We found 4 models of A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEMHIGH PLATE LEFT by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Jan 20, 2022 and Oct 18, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

2 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEMHIGH PLATE LEFT recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 14, 2020Class IITerminated

   Distributed to the field without having completed design history files or design transfer activities

   Z-2320-2020 · Root cause: Device Design · Recall details · FDA record ↗

2. May 14, 2020Class IITerminated

   Distributed to the field without having completed design history files or design transfer activities

   Z-2319-2020 · Root cause: Device Design · Recall details · FDA record ↗

Most reported A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEMHIGH PLATE LEFT problems

A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEMHIGH PLATE LEFT models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• A.L.P.S.® PROXIMAL HUMERUS PLATING SYSTEMHIGH PLATE LEFT 110030307

  Plate, fixation, bone
  1 recall0 reports
• A.L.P.S.® PROXIMAL HUMERUS PLATING SYSTEMHIGH PLATE LEFT 110030308

  Plate, fixation, bone
  1 recall0 reports
• A.L.P.S.® PROXIMAL HUMERUS PLATING SYSTEMHIGH PLATE LEFT 110030301

  Plate, fixation, bone
  1 report
• A.L.P.S.® PROXIMAL HUMERUS PLATING SYSTEMHIGH PLATE LEFT 110030305

  Plate, fixation, bone
  1 report

Recent A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEMHIGH PLATE LEFT adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2022Unsealed Device Packaging; Unsealed Device Packaging

  NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15627597 ↗
• InjuryJan 20, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED IN A STUDY THAT ONE OF THE LOCKING SCREWS WAS PULLED OUT. THE PATIENT WAS ENROLLED AS SUBJECT IN A STUDY AND WHEN HE VISITED THE HOSPITAL FOR HIS THREE MONTH FOLLOW-UP VISIT WHERE SCREW REMOVAL WAS FOUND. THE PULLED SCREW CAME OUT THROUGH THE SKIN AND THE PATIENT MANUALLY REMOVED IT BY HIMSELF. THE PATIENT HAD MODERATE PAIN AND AFTER THE REMOVAL OF SCREW, THE PAIN WAS RELIEVED. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Pain

  MAUDE report 13306601 ↗

Other Biomet Orthopedics, LLC products

• AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
• AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
• Compress Device71 models · 99 reports · 22 recalls
• Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
• Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
• Vanguard Knee System147 models · 306 reports · 13 recalls
• STAGEONE17 models · 0 reports · 18 recalls
• StageOne Select15 models · 2 reports · 15 recalls