SOLUTION SYSTEM 1257-35-000Recalls & reported problems
Depuy Orthopaedics, Inc. · SOLUTION SYSTEM PERIPHERAL BONE SCREW 5.0mm x 35mm · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295019886), received between Jul 10, 2018 and May 15, 2019 — classified as 4 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Loss of Osseointegration2
- Osseointegration Problem2
- Failure to Osseointegrate1
- Fracture1
- Loose or Intermittent Connection1
Patient problems
- Inadequate Osseointegration4
- Discomfort2
- Inflammation2
- Pain2
- No Code Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem
PPF ALLEGES LOOSENING OF CUP AND BONE FRACTURE. DOI: (B)(6) 2007 - DOR: (B)(6) 2009 (LEFT HIP) FIRST REVISION.
Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; Pain
MAUDE report 8611381 ↗InjuryMay 15, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem
PPF ALLEGES LOOSENIG OF CUP AND BONE FRACTURE. DOI: (B)(6) 2007, DOR: (B)(6) 2009 (LEFT HIP), FIRST REVISION.
Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; Pain
MAUDE report 8611373 ↗InjuryOct 1, 2018Fracture; Failure to Osseointegrate; Fracture; Failure to Osseointegrate
IT WAS REPORTED THAT THE CUP CAME LOOSE AT THE BONE TO IMPLANT INTERFACE AND BOTH PERIPHERAL SCREWS BROKE.
Patient problems: Inadequate Osseointegration; No Code Available
MAUDE report 7923395 ↗InjuryJul 10, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE CUP COMPONENT AT BONE TO IMPLANT INTERFACE. REMOVED CUP AND LINER AND IMPLANTED NEW CUP. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.
Patient problems: Inadequate Osseointegration
MAUDE report 7673275 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.