GRIPTION 1217-25-800Recalls & reported problems
Depuy (Ireland) · GRIPTION TF SCREW 5.5mm x 25mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295381365), received between Feb 26, 2020 and Jan 5, 2026 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (4 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.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping4
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Hematoma2
- Hip Fracture2
- No Code Available2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING INSPECTION AND RECEIPT A HAIR WAS FOUND INSIDE THE PLASTIC PACKAGING OF THE 5.5X25MM GRIPTION TF STE SCREW. THERE WAS NO PATIENT OR USER HARM, NO DELAY. THE EVENT WAS UNRELATED TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23962706 ↗MalfunctionOct 29, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A NURSE STATED THAT A COUPLE OF SCREWS WERE UNSEALED. THE OUTER PACKAGE SEALED BUT INNER PACKAGE OPENED IN ONE OF THE SIDES. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20555999 ↗MalfunctionOct 29, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A NURSE STATED THAT A COUPLE OF SCREWS WERE UNSEALED. THE OUTER PACKAGE SEALED BUT INNER PACKAGE OPENED IN ONE OF THE SIDES. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20555892 ↗MalfunctionOct 29, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A NURSE STATED THAT A COUPLE OF SCREWS WERE UNSEALED. THE OUTER PACKAGE SEALED BUT INNER PACKAGE OPENED IN ONE OF THE SIDES. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20555865 ↗InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AFTER REVIEW OF MEDICAL RECORDS, IT WAS REPORTED THAT THE PATIENT GOT UP OUT OF BED AND TORE THE ACETABULAR COMPONENT OUT, FRACTURED AROUND IT. THEN THE PATIENT WAS REVISED FOR DISPLACED LEFT ACETABULAR COMPONENT/ PERIPROSTHETIC FRACTURE. OPERATIVE NOTES REPORTED THAT ABOUT 300 ML HEMATOMA WAS EXPELLED. THE CONSTRAINED LINER WAS STILL LOCKED AROUND THE PROSTHETIC BALL BUT IT HAD TORN THE SHELL OUT OF HER NATIVE ACETABULAR FOSSA. SCREWS HAS BEEN ADDED TO THE COMPLAINT. DOI: (B)(6) 2017; DOR: (B)(6) 2017; LEFT HIP.
Patient problems: Hematoma; Hip Fracture; No Code Available
MAUDE report 9756446 ↗InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AFTER REVIEW OF MEDICAL RECORDS, IT WAS REPORTED THAT THE PATIENT GOT UP OUT OF BED AND TORE THE ACETABULAR COMPONENT OUT, FRACTURED AROUND IT. THEN THE PATIENT WAS REVISED FOR DISPLACED LEFT ACETABULAR COMPONENT/ PERIPROSTHETIC FRACTURE. OPERATIVE NOTES REPORTED THAT ABOUT 300 ML HEMATOMA WAS EXPELLED. THE CONSTRAINED LINER WAS STILL LOCKED AROUND THE PROSTHETIC BALL BUT IT HAD TORN THE SHELL OUT OF HER NATIVE ACETABULAR FOSSA. SCREWS HAS BEEN ADDED TO THE COMPLAINT. DOI: (B)(6) 2017; DOR: (B)(6) 2017; LEFT HIP.
Patient problems: Hematoma; Hip Fracture; No Code Available
MAUDE report 9756423 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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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