SMR Shoulder 9013.52.147Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390152068), received between Jan 7, 2025 and May 5, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K100858); 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025Break; Break

  AFTER A SHOULDER SURGERY PERFORMED ON (B)(6) 2025, THE OPERATIONS COORDINATOR IN THE SUBSIDIARY'S WAREHOUSE WAS CHECKING THE INSTRUMENT SET THAT WAS RETURNED FROM THE HOSPITAL AND FOUND THAT THE TIP OF THE REVERSE ADAPTOR SLEEVE (PRODUCT CODE 9013.52.147, LOT #22BH0AK) WAS BROKEN. THERE IS NO INFORMATION AS TO HOW THE DEVICE BROKE. STILL, NO CONSEQUENCES WERE REPORTED. EVENT HAPPENED IN AUSTRALIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960276 ↗
• MalfunctionJan 7, 2025Break; Break

  DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2024, THE FRONT PART OF THE REVERSE ADAPTOR SLEEVE (PRODUCT CODE: 9013.52.147, LOT#: 23BH002) FOR THE CONNECTION WITH THE HUMERAL BODY TRIAL IS BROKEN WHEN THE SURGEON TRIED TO TAKE OUT THE TRIAL FROM THE HUMERAL CAVITY. DUE TO THE BROKEN INSTRUMENT, IT WAS DIFFICULT TO TAKE OUT THE TRIAL FROM THE HUMERAL CAVITY. NO OTHER INSTRUMENT WAS AVAILABLE: THE SURGEON HELD THE TRIAL WITH A RONGEUR AND KNOCKED IT OUT CAREFULLY. IT WAS REPORTED THAT THE INSTRUMENT WAS USED ABOUT 10 TIMES. THE SURGERY GOT PROLONGED FOR 40 MINUTES. PATIENT IS A FEMALE, 61 YEARS OLD. EVENT HAPPENED IN CHINA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091068 ↗
• MalfunctionJan 7, 2025Break; Break

  DURING PRIMARY SHOULDER SURGERY PERFORMED ON (B)(6) 2024 THE FRONT PART REVERSE ADAPTOR SLEEVE (PRODUCT CODE 9013.52.147, LOT #2117361) FOR THE CONNECTION WITH THE HUMERAL BODY TRIAL GETS BROKEN WHEN THE SURGEON TRIED TO TAKE OUT THE TRIAL FROM THE HUMERAL CAVITY. DUE TO THE BROKEN INSTRUMENT, IT WAS DIFFICULT TO TAKE OUT THE TRIAL FROM THE HUMERAL CAVITY. NO OTHER INSTRUMENT WAS AVAILABLE: THE SURGEON HELD THE TRIAL WITH A RONGEUR AND KNOCKED IT OUT CAREFULLY. ACCORDING TO THE RECEIVED INFORMATION, THE INSTRUMENT WAS USED ABOUT 20 TIMES. THE SURGERY GOT PROLONGED FOR 40 MINUTES. PATIENT IS A MALE, 71 YEARS OLD. EVENT HAPPENED IN CHINA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091067 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100858. One submission often covers many models, so check the product and lot details in each record.

• Z-2540-2015 · Aug 14, 2015 · Terminated
  SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
• Z-2539-2015 · Aug 14, 2015 · Terminated
  SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral