Skip to content

SMR System 1306.15.160Recalls & reported problems

Limacorporate SPA · SMR System - Cemented Stem Dia. 16 mm L. 80 mm · Class 2 · Implant

All models of SMR System (47)

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 08033390270991), received between May 17, 2023 and May 17, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

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

Device problems

  • Patient Device Interaction Problem1

Patient problems

  • Implant Pain1
  • Loss of Range of Motion1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

    SHOULDER REVISION SURGERY DUE TO PAIN AND RADIOLOGICAL LOOSENING OF REVISION SHOULDER REPLACEMENT. REVISION SURGERY DATE IS (B)(6) 2021. THE FOLLOWING DEVICES WERE EXPLANTED DURING THE REVISION SURGERY: - SMR CEMENTED STEM Ø16 MM CODE 130615160, LOT 1601346. - SMR REVERSE HUMERAL BODY SHORT CODE 135215005, LOT 1704554. - SMR REVERSE LINER STANDARD CODE 136050010, LOT 17AT1NZ. - SMR GLENOSPHERE Ø36MM SMALL-R CODE137409105, LOT 1713817. - SMR GLENOID PEG TT SMALL-R #XL CODE 137514654, LOT 1712226. - SMR GLENOID BASEPLATE SMALL-R, CODE 137515650, LOT 1712220. - BONE SCREW Ø6,5 H.40MM CODE 842015050, LOT 1711901. BASED ON THE AVAILABLE INFORMATION, THE PATIENT HAD A PREVIOUS REVISION SURGERY DUE TO INFECTION AND A FURTHER REVISION SURGERY ON (B)(6) 2018, WHEN LIMA DEVICES WERE IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED INCREASED PAIN AROUND THE LATERAL ASPECT OF THE SHOULDER AND DECREASED RANGE OF MOVEMENT. IN 2019 THE INFECTION RECURRED AND WAS TREATED WITH ANTIBIOTICS AND OPEN BIOPSY. THE LAST REVISION SURGERY (OBJECT OF THIS REPORT, FIRST REVISION SURGERY OF LIMA DEVICES) WAS THEN PERFORMED IN 2021. EVENT OCCURRED IN THE UNITED KINGDOM. NOTE: AMONG THE LISTED DEVIC

    Patient problems: Implant Pain; Loss of Range of Motion

    MAUDE report 16945188 ↗

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

Other Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices

All Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page