MRS 6487-1-040Recalls & reported problems
Howmedica Osteonics Corp. · Humeral Module · Class 2 · Implant
All models of MRS (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327048940), received between Apr 18, 2023 and Oct 22, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration1
- Pain1
- Periprosthetic fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: AS PER PSS IMPLANT REQUEST: LOOSENING GMRS PROXIMAL HUMERUS PROSTHESIS WITH PATHOLOGICAL FRACTURE. HISTORY OF PERIOSTEAL CHONDROSARCOMA PROXIMAL HUMERUS, EXCISION AND REPLACEMENT WITH GMRS PROXIMAL HUMERUS DONE IN 2015, DEFAULTED FOLLOW UP, CAME BACK WITH LOOSENING WITH PERIPROSTHETIC FRACTURE, BIOPSY REVEALED NO EVIDENCE OF TUMOUR RECURRENCE. PLAN FOR REVISION.
Patient problems: Periprosthetic fracture
MAUDE report 23360550 ↗InjuryApr 18, 2023Loss of Osseointegration; Loss of Osseointegration
IT HAS BEEN REPORTED "REPORTED BY DISTRIBUTOR THAT PATIENT PAIN, IMPLANT LOOSENING, AFTER X RAY, SURGEON SUGGEST TO PERFORM THE REVISION AND THE REVISION DATE IS NOT IDENTIFIED. YET."
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 16760239 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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