Torx 2030-6540-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327037029), received between Mar 7, 2017 and Nov 22, 2024 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 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.

• InjuryNov 22, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO 'LOOSE ACETABULAR SOCKET.' ALSO REPORTED WERE 'CONTINUED PAIN AND MAINLY GROIN AND LATERAL PAIN' SHELL, SCREWS, LINER, AND FEMORAL HEAD WERE REVISED TO A COMPETITOR SHELL, SCREWS, AND LINER, AND A STRYKER LFIT HEAD.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 20756053 ↗
• InjuryNov 18, 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 15822611 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED FROM A 60MM TRITANIUM HEMI CLUSTER SHELL, 6.5 X 40 MM BONE SCREW, TRIDENT 0° POLY INSERT, 36+0 CERAMIC V40 HEAD TO A 64 MM TRIDENT II MULTIHOLE SHELL, TRIDENT 10° POLY INSERT, AND LFIT V40 HEAD WITH THREE BONE SCREWS. SPOKE TO REP: ORIGINAL DIAGNOSIS WAS SHELL LOOSENING. HOWEVER, INTRA-OPERATIVELY THE SHELL WAS REPORTED AS WELL-FIXED AND DIFFICULT TO REMOVE. A SCREW WAS USED TO REMOVE THE SHELL. THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY HOSPITAL OR SURGEON AND THAT EXPLANTS ARE NOT AVAILABLE FOR RETURN.

  Patient problems: No Information

  MAUDE report 11129715 ↗
• MalfunctionAug 20, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO ASEPTIC LOOSENING OF THE SHELL AND TWO BROKEN SCREWS. INTRA-OPERATIVELY, WEAR WAS NOTED ON THE FEMORAL HEAD. THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. PATIENT WAS REVISED TO A TRIDENT 2 SHELL, MDM METAL LINER, ADM/MDM POLY INSERT, AND A BIOLOX HEAD WITH SLEEVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10434995 ↗
• InjuryJul 22, 2019Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO LOOSENING OF THE SHELL. INTRA-OPERATIVELY, CORROSION WAS NOTED ON THE SCREWS. THE SHELL, 2 SCREWS AND POLY LINER WERE REVISED. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8811273 ↗
• InjurySep 28, 2018Migration; Migration

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S ENTIRE LEFT HIP CONSTRUCT WAS REVISED 16 DAYS AFTER IMPLANTATION. A 52MM CLUSTER HOLE SHELL WITH 2 SCREWS, 36D LINER, 36 -5 CERAMIC HEAD, AND 5X108 STEM WERE REVISED TO A 60MM CLUSTER HOLE SHELL WITH 7 SCREWS, AN ADM/MDM LINER CONSTRUCT, 28 +0 METAL HEAD, AND A 6X111 STEM. UPDATE 31-AUGUST-2018: REP REPORTED THAT PATIENT WAS REVISED DUE TO MOVEMENT OF THE SHELL (DESCRIBED AS HAVING SPUN IN ACETABULUM). SURGEON DECIDED TO IMPLANT A LARGER SHELL AND REVISE THE REST OF THE CONSTRUCT TO SUIT. THERE ARE NO ALLEGATIONS AGAINST THE LINER, HEAD, OR STEM.

  Patient problems: Injury

  MAUDE report 7918320 ↗
• MalfunctionFeb 16, 2018Component Missing; Packaging Problem; Component Missing; Packaging Problem

  IT WAS REPORTED THAT THE TORX CANCELLOUS BONE SCREW BOX WAS OPENED AND FOUND TO CONTAIN NO BLISTER PACK NOR WAS THERE A SCREW. THE CONTAINER HAD THE ORIGINAL PLASTIC WRAP ON IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7278408 ↗
• MalfunctionMar 7, 2017Break; Break

  DURING SCORPIO NRG SURGERY FOR LEFT KNEE, THE METAL PIECE WAS FOUND FROM TWO SCREWS AFTER THE INSERTION OF THE SCREWS. THE SURGEON REMOVED THE PIECES AND FINISHED THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6385085 ↗
• MalfunctionMar 7, 2017Break; Break

  DURING SCORPIO NRG SURGERY FOR LEFT KNEE, THE METAL PIECE WAS FOUND FROM TWO SCREWS AFTER THE INSERTION OF THE SCREWS. THE SURGEON REMOVED THE PIECES AND FINISHED THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6385079 ↗

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-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-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-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-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-2121-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 40 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op
• Z-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-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
• 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-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-2134-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 15 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430.
• 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-2117-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 16 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op

…and 17 more.