SUMMIT 2570-03-050Recalls & reported problems
Depuy (Ireland) · SUMMIT NECK SEGMENT SIZE 0/1 HI · Class 1
All models of SUMMIT (43)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295143062), received between Jul 5, 2018 and Jan 22, 2025 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Material Discolored2
- Material Twisted/Bent2
- Corroded1
- Device-Device Incompatibility1
- Illegible Information1
- Naturally Worn1
Patient problems
- No Consequences Or Impact To Patient6
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2025. DURING THE PROCEDURE, RING ON SUMMIT 0/1 HI OFFSET NECK TRIAL BROKE OFF. NO FRAGMENTS WERE GENERATED. ANOTHER SUMMIT TRAY WAS OPENED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21211222 ↗MalfunctionJul 10, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE 0/1 HIGH NECK SEGMENT LOCKING RING IS MALFUNCTIONING. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19716017 ↗MalfunctionNov 1, 2022Break; Break
IT WAS REPORTED THAT DURING HIP ARTHROPLASTY, TWO ITEMS WERE DAMAGED DURING SURGERY .WE HAD BACKUP ITEMS AVAILABLE, SO THERE WERE NO DELAYS OR PROBLEMS IN SURGERY BECAUSE OF THIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15708202 ↗MalfunctionJan 25, 2022Illegible Information; Illegible Information
SIZE LABELING IS NOT LEGIBLE ON INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13347465 ↗MalfunctionOct 27, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE HEAD IS LOOSE ON THE TRIAL. THE WASHER APPEARS WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12705338 ↗MalfunctionNov 16, 2020Break; Break
BOTH ACTIS AND SUMMIT HIGH OFFSET TRIAL NECKS ARE BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10845021 ↗MalfunctionMar 10, 2020Material Twisted/Bent; Material Twisted/Bent
MalfunctionMar 10, 2020Material Twisted/Bent; Material Twisted/Bent
MalfunctionJul 5, 2018Corroded; Corroded
THE MATERIALS PRESENTED OXIDATION. (B)(6). D257003150 NECK 2/3 HI LOT MT47132, D258003400 NECK 8/9 ST LOT MT447377, D2577003050 NECK 0/1 HI LOT MT40595, D267003200 NECK 4/5 ST LOT MT47047, D257003300 NECK ST 6/7 LOT MT47294, D24400549 STRAWBERRY 49 LOT S02019713, D24400542 STRAWBERRY 42 LOT S02015959.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7663602 ↗MalfunctionJul 5, 2018Material Discolored; Material Discolored
PRODUCTS PRESENTED OXIDATION. IN THE EMAIL RECEIVED, CAME A LIST OF PRODUCTS SEPARATED BY BOX. THIS COMPLAINT REFERS TO THE PRODUCTS OF (B)(6) IN BOX 2. PRODUCT: 257003050, LOT: MT40695. PRODUCT: 257003100, LOT: MT44718. PRODUCT: 257003150, LOT: MT47132. PRODUCT: 257003250, LOT: MT47299. PRODUCT: 257003350, LOT: MT45600. PRODUCT: 257003400, LOT: MT44738.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7663430 ↗MalfunctionJul 5, 2018Material Discolored; Material Discolored
PRODUCTS PRESENTED OXIDATION. IN THE EMAIL RECEIVED, CAME A LIST OF PRODUCTS SEPARATED BY BOX. THIS COMPLAINT REFERS TO THE PRODUCTS OF (B)(6) HOSPITAL IN BOX 1. (B)(6). PRODUCT: 257003050, LOT: MT40595. PRODUCT: 257003250, LOT: MT47299. PRODUCT: 257003350, LOT: MT45800. PRODUCT: 257003200, LOT: MT47074. PRODUCT: 257003300, LOT: MT47294.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7663391 ↗
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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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