INSTRUMENT 1020-1860Recalls & reported problems
Howmedica Osteonics Corp. · MODULAR OFFSET QUICK CONNECT STEM INSERTER · Class 2
All models of INSTRUMENT (131)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327252910), received between Mar 8, 2021 and Aug 22, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
- Material Fragmentation2
- Degraded1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2022Degraded; Fracture; Degraded; Fracture
DURING HIP PROCEDURE, SURGEON REPORTED THAT A MEDICAL EQUIPMENT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15263908 ↗InjuryMay 3, 2022Fracture; Material Fragmentation; Fracture; Material Fragmentation
X-RAY RIGHT AFTER THE THA SHOWS METAL PIECE IN THE BODY. REOPEN INCISION. THE PIECE WAS THE TIP OF IMPACTOR.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 14266055 ↗MalfunctionMar 8, 2021Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem
SURGEON WAS USING THE MODULAR OFFSET STEM INSERTER FOR THE ACCOLADE II STEM, AND WHEN IMPACTING THE STEM INTO THE FEMORAL CANAL, A SMALL METAL CHIP BROKE OFF. SURGEON REMOVED CHIP AND STEM WAS SUCCESSFULLY INSERTED. MODULAR OFFSET STEM INSERTER AND CHIP HAVE BEEN ACQUIRED FOR ANALYSIS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11437292 ↗
Other Prosthesis, hip, constrained, cemented or uncemented, metal/polymer devices
- Novation 134-36-45Exactech, Inc. · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2 recalls0 reports
- PINNACLE 1218-28-650Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer89 reports
- Trident 690-00-28FHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall37 reports
- Trident 690-00-22EHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall36 reports
- PINNACLE 1218-32-652Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer75 reports
- Trident 690-00-22DHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall22 reports
- PINNACLE 1218-32-654Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer70 reports
- Trident 69-2850Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall11 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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