Torx 2030-6520-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327036985), received between Jun 25, 2018 and Feb 15, 2023 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (3 reports).

32 other recalls cover devices cleared under the same FDA submission (K873251, K894124); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS BACKSIDE WEAR-LIKE OSTEOLYSIS AROUND THE SCREW HOLE OF TRIDENT CUP. AN INDENTATION MADE BY THE SCREW HEAD WAS OBSERVED ON THE BACKSIDE OF THE LINER.

  Patient problems: Osteolysis

  MAUDE report 16383279 ↗
• InjuryNov 17, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY THE SALES REP THAT THE SURGEON NOTIFY ON A POSSIBLE REMOVAL CASE DUE TO LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15812797 ↗
• InjuryMar 22, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY (POSSIBLE CAUSE OR CONTRIBUTOR FOR INSTABILITY NOT REPORTED TO REP). A SHELL, TWO SCREWS, AND A LINER WERE REVISED TO A TRITANIUM REVISION SHELL AND MDM/ ADM LINER CONSTRUCT. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Injury; Joint Laxity

  MAUDE report 8443181 ↗
• MalfunctionNov 15, 2018Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT, DURING A THA, WHEN A NURSE WAS PEELING THE TYVEK SHEET, IT WAS DELAMINATED. A SPARE WAS USED INSTEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8073998 ↗
• InjurySep 25, 2018Fracture; Fracture

  IT WAS REPORTED THAT:"IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PATIENT, AS A RESULT OF A LAWSUIT, THAT ALLEGEDLY THE PATIENT RECEIVED A TRIDENT CERAMIC ON CERAMIC HIP SYSTEM. IT WAS FURTHER ALLEGED THAT, THE PATIENT BEGAN TO EXPERIENCE SOME DIFFICULTIES, REQUIRING A REVISION SURGERY ON (B)(6) 2008." UPDATE AS PER MEDICAL REVIEW: "ON (B)(6) 2008 A REVISION OF THE RIGHT TOTAL HIP WAS PERFORMED WITH REMOVAL OF LOOSE, FRACTURED CERAMIC PIECES. EXTENSIVE METALLOSIS WAS NOTED AND A REVISION TOTAL HIP WAS PERFORMED FOR A DIAGNOSIS OF FRACTURED CERAMIC HEAD AND LINER, DISPLACED METAL LINER, EROSION SUPERIOR ACETABULAR SHELL, AND EXTENSIVE WEAR DEBRIS."

  Patient problems: Device Embedded In Tissue or Plaque; Inflammation; Injury; Reaction

  MAUDE report 7907782 ↗
• InjurySep 21, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT:"IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PATIENT, AS A RESULT OF A LAWSUIT, THAT ALLEGEDLY THE PATIENT RECEIVED A TRIDENT CERAMIC ON CERAMIC HIP SYSTEM. IT WAS FURTHER ALLEGED THAT, THE PATIENT BEGAN TO EXPERIENCE SOME DIFFICULTIES, REQUIRING A REVISION SURGERY ON (B)(6) 2008." UPDATE AS PER MEDICAL REVIEW: "ON (B)(6) 2008 A REVISION OF THE RIGHT TOTAL HIP WAS PERFORMED WITH REMOVAL OF LOOSE, FRACTURED CERAMIC PIECES. EXTENSIVE METALLOSIS WAS NOTED AND A REVISION TOTAL HIP WAS PERFORMED FOR A DIAGNOSIS OF FRACTURED CERAMIC HEAD AND LINER, DISPLACED METAL LINER, EROSION SUPERIOR ACETABULAR SHELL, AND EXTENSIVE WEAR DEBRIS."

  Patient problems: Device Embedded In Tissue or Plaque; Inflammation; Injury; Reaction

  MAUDE report 7897812 ↗
• MalfunctionAug 31, 2018Packaging Problem; Packaging Problem

  PACKAGING OF SCREW LOOKED COMPROMISED. CIRCULATOR NOTICED BEFORE SCREW WAS PLACED ON STERILE FIELD. OPENED NEW SCREW AND PROCEEDED ON WITH CASE, THERE WAS NO DELAY TO SURGERY. PER REP, PACKAGING "APPEARS TO BE DISCOLORED AND THAT IS THE SOLE REASON FOR REPORTING."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7837161 ↗
• MalfunctionJul 9, 2018Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT, DURING A THA, WHEN A NURSE PEELED THE OUTER TYVEK SHEET, IT WAS DELAMINATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7669694 ↗
• InjuryJun 25, 2018Crack; Fracture; Crack; Fracture

  IT WAS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LEGAL CLAIM, THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011 WHERE SHE WAS IMPLANTED WITH A STRYKER HIP SYSTEM. IT IS FURTHER ALLEGED THAT THE PATIENT BEGAN EXPERIENCING RIGHT HIP PAIN AND WAS USING A WALKER FOR AMBULATION. X-RAYS TAKEN IN 2016 "REVEALED A BROKEN SCREW WITHIN THE ACETABULAR COMPONENT AND MEDIAL MIGRATION OF THE ACETABULAR COMPONENT CAUSING PROTRUSION". THE PATIENT THEN UNDERWENT REVISION SURGERY OF THE RIGHT HIP ACETABULAR COMPONENT ON (B)(6) 2017.

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain

  MAUDE report 7635451 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K873251, K894124. One submission often covers many models, so check the product and lot details in each record.

• Z-0483-2014 · Oct 1, 2013 · Terminated
  Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5
• Z-0388-2013 · Aug 17, 2012 · Terminated
  Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell i
• Z-0387-2013 · Aug 17, 2012 · Terminated
  Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell i
• Z-2128-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 30 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op
• Z-2176-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 35 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op
• Z-2141-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 50 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
• Z-2142-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 55 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
• Z-2123-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 50 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op
• Z-2130-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 40 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op
• Z-2122-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 45 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op
• Z-2136-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 25 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
• Z-2138-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 35 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
• Z-2140-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 45 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
• Z-2126-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 20 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op
• Z-2125-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 15 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op

…and 17 more.