Torx 2030-6516-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327036978), received between Jan 2, 2018 and Jul 1, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Degraded

  AS PER MEDWATCH REPORTS MW5188325, MW5188326, MW5188327, MW5188328, MW5188329, MW5188330, MW5188331, MW5188332: REPORTER STATES SHE HAD A COMPLETE HIP REVISION ON (B)(6) 2026 DUE TO HER PREVIOUS HIP IMPLANT LEAKING COBALT INTO HER BLOODSTREAM. REPORTER IS STILL RECOVERING FROM THE REVISION 5 WEEKS AGO AND SHE HAS EXPERIENCED DIFFICULTY WALKING. REPORTER HAD THE INITIAL IMPLANT ON (B)(6) 2012 WITH DR. (B)(6) HOSPITAL. PT STARTED EXPERIENCING EXTREME FATIGUE, HEADACHES, COGNITIVE ISSUES, BODY ACHES, SHORTNESS OF BREATH AFTER MILD ACTIVITY AND JOINT PAIN FOR THE LAST COUPLE OF YEARS. WITHIN THE TIMEFRAME REPORTER ALSO EXPERIENCED CHRONIC FATIGUE SYNDROME. SHE HAD MULTIPLE TESTING DONE SUCH AS X-RAY AND MRI THAT WEREN'T CONCLUSIVE UNTIL SHE HAD A SPECIFIC MRI THAT SHOWED METALS IN BLOODSTREAM AND LAB WORK THAT SHOWED HEAVY METAL DAMAGE. SHE ALSO HAD HER GALLBLADDER REMOVED AND SUSPECTS IT MAY BE DUE TO HEAVY METALS IN BODY. REPORTER STATES THAT SHE HAS SEEN RECALLS ON THESE TYPE OF DEVICES.

  Patient problems: Cognitive Changes; Dyspnea; Fatigue; Headache; Metal Related Pathology; Pain

  MAUDE report 25682839 ↗
• InjuryJun 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT REQUIRED A REVISION OF THE CUP TODAY DUE TO IT LOOSENING. THE ORIGINAL CASE WAS (B)(6) 2020; DUE TO PATIENT ANATOMY AT THAT TIME, THE SURGEON OPTED TO USE A TRIDENT TITANIUM MULTIHOLE (509-02-56E). SURGEON REQUESTED SCREWS. TORX SCREWS WERE PROVIDED (2030-6516-1 AND 2030-6530-1). LINER WAS IMPACTED AND THE FEMUR WAS COMPLETED. I BECAME AWARE TODAY ((B)(6) 2020) THAT THE PATIENT REQUIRED A REVISION OF THE CUP.

  Patient problems: Injury

  MAUDE report 10105432 ↗
• InjuryOct 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF RIGHT TOTAL HIP. LOOSENING OF ACETABULAR SHELL DUE TO POOR BONE DISCOVERED ON FOLLOW UP X-RAY AT 6 MONTH. CEMENTED EXETER RIMFIT CUP INSERTED. ORIGINAL SURGERY (B)(6) 2019. THIS IS ALL THE INFORMATION AVAILABLE.

  Patient problems: Injury

  MAUDE report 9145846 ↗
• MalfunctionOct 9, 2018Packaging Problem; Packaging Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7946916 ↗
• InjurySep 25, 2018Fracture; Fracture

  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 7907783 ↗
• MalfunctionAug 17, 2018Unsealed Device Packaging; Unsealed Device Packaging

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7793793 ↗
• MalfunctionJan 2, 2018Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT, DURING A THA, WHEN A NURSE PEELED THE OUTER TYVEK SHEET, THE INNER BLISTER ALSO PICKED UP WITH OUTER TYVEK AND FELL DOWN ON THE FLOOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7156810 ↗

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-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-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-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-2139-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 40 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-2132-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Bone Screw; Dia 6.5 mm; Lnth: 25 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are optional fixt
• Z-2135-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 20 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
• Z-2120-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 30 mm; Sterile; Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op
• Z-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
• 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-2127-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 25 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op
• 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-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-2118-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 20 mm; Sterile Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are opt

…and 17 more.