Torx 2030-6535-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327037012), received between Jan 11, 2017 and Apr 22, 2025 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2025Fracture; Fracture

  THE FOLLOWING WAS REPORTED BY THE CUSTOMER: "DURING IMPLANTATION THE SCREW HEAD SNAPPED OFF - UNABLE TO REMOVE REMAINING METAL IMPLANT." FURTHER INFORMATION RECEIVED FROM CUSTOMER 1/4; " THE SURGEON WAS UNABLE TO SAFELY REMOVE THE REMAINING PARTS OF THE SCREW. TO AVOID IT IMPINGING ON THE CUP THE DECISION WAS MADE TO USE A BURR TO ENSURE THE BROKEN SCREW WAS FLUSH. NO LONG LASTING EFFECTS PREDICTED.

  Patient problems: Metal Related Pathology; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21886565 ↗
• 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 20756058 ↗
• InjuryMar 17, 2022Fracture; Fracture

  THIS PI IS FOR THE 2017 HIP REVISION OF UNKNOWN REASON. ITS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LAWSUIT, THAT THE PLAINTIFF UNDERWENT REVISION RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2017, WHERE SHE WAS IMPLANTED WITH A STRYKER HIP SYSTEM. ITS FURTHER ALLEGED THAT THE PATIENTS RIGHT HIP HAD TO BE REVISED AGAIN ON (B)(6) 2018 DUE TO ACETABULAR COMPONENT LOOSENING. UPDATE ON 22-FEB-2022 PER CLINICIAN REVIEW: ON (B)(6) 2017, A 'RIGHT REVISION TOTAL HIP ARTHROPLASTY' WAS PERFORMED FOR A 'PRE- AND POST-OPERATIVE DIAGNOSIS OF ASEPTIC LOOSENING RIGHT TOTAL HIP ARTHROPLASTY'. THE OPERATIVE REPORT NOTES, ACETABULAR COMPONENT WAS GROSSLY LOOSE, SCREW WAS BROKEN, DISTAL END OF SCREW, REMAINED DEEP IN THE BONE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13796000 ↗
• InjuryFeb 4, 2022Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2014 AND WAS REVISED ON (B)(6) 2019. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. UPDATE 1: "ACCORDING TO THE (B)(6) 2019 REVISION OPERATIVE REPORT, HE HAD PERSISTENT PAIN AND WAS REVISED 5 YEARS AGO. AT SURGERY HIS ACETABULAR COMPONENT WAS FOUND TO BE IN RETROVERSION. A NEW STRYKER ACETABULAR COMPONENT WAS PLACED ALONG WITH NEW STRYKER HEAD ON HIS ACCOLADE STEM." UPDATE 2: AS PER MED REVIEW AND REVISION NOTES: ADD IN 2 SCREWS FOR LOOSENING AND 1 BONE SCREW ALSO FRACTURED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 13452977 ↗
• InjuryFeb 4, 2022Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2014 AND WAS REVISED ON (B)(6) 2019. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. UPDATE 1: "ACCORDING TO THE (B)(6) 2019 REVISION OPERATIVE REPORT, HE HAD PERSISTENT PAIN AND WAS REVISED 5 YEARS AGO. AT SURGERY HIS ACETABULAR COMPONENT WAS FOUND TO BE IN RETROVERSION. A NEW STRYKER ACETABULAR COMPONENT WAS PLACED ALONG WITH NEW STRYKER HEAD ON HIS ACCOLADE STEM." UPDATE 2: AS PER MED REVIEW AND REVISION NOTES : ADD IN 2 SCREWS FOR LOOSENING AND 1 BONE SCREW ALSO FRACTURED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 13452936 ↗
• InjuryJun 17, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6) 2011 AND WAS REVISED ON (B)(6) 2019. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. UPDATE: HEAD DISASSOCIATION. UPDATE: METALLOSIS, LOOSE ACETABULAR COMPONENT.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Metal Related Pathology

  MAUDE report 12015114 ↗
• MalfunctionMar 30, 2021Fracture; Osseointegration Problem; Fracture; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SHELL LOOSENING AND MIGRATION, AND A BROKEN SCREW. THERE WAS NO KNOWN CAUSE OR CONTRIBUTOR FOR THE LOOSENING OR MIGRATION. THERE ARE NO ALLEGATIONS AGAINST ANY OTHER IMPLANTS. A 50D CLUSTER HOLE SHELL AND TORX BONE SCREW WERE REVISED TO A 58F TRITANIUM SHELL WITH HEX SCREWS. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11590094 ↗
• MalfunctionNov 20, 2019Mechanical Problem; Mechanical Problem

  DR COMMENTED THAT ON POST OP X-RAY THE MDM LINER DIDN¿T LOOK SEATED IN TRIDENT CUP ALTHOUGH AT TIME OF OPERATION IT WAS SOLID & APPEARED TO BE SOLID.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9351273 ↗
• 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 9145845 ↗
• InjuryJun 5, 2019Break; Break

  A 54MM TITANIUM CUP WAS LOOSE AND REQUIRED REVISING. THE SINGLE SCREW IN THE CUP WAS BROKEN UPDATE: RIGHT SIDE.

  Patient problems: Injury

  MAUDE report 8670251 ↗
• MalfunctionAug 15, 2018Difficult to Insert; Mechanical Jam; Difficult to Insert; Mechanical Jam

  SURGEON COMPLAINED THE TWO TORX SCREWS APPEARED TO NOT BE BEHAVING AS EXPECTED WHEN USING THEM. THE SCREWS REPORTEDLY WERE NOT PROGRESSING INTO THE BONE AS THE THREADS SEEMED TO BE AFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7786467 ↗
• InjuryJul 12, 2018Crack; Insufficient Device Problem Information; Crack; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO COMPLICATIONS OF THE ACETABULAR SHELL (COMPLICATIONS NOT SPECIFIED TO REP). INTRA-OPERATIVELY, ONE SCREW WAS REPORTED BROKEN (UNKNOWN IF SCREW BROKE IN EXTRACTION OR AT SOME POINT AFTER IMPLANTATION). REP PROVIDED PRIMARY IMPLANT SHEET AND PRE-REVISION X-RAYS AND REPORTED THAT ADDITIONAL X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION WILL NOT BE RELEASED BY THE SURGEON OR HOSPITAL.

  Patient problems: Injury

  MAUDE report 7682654 ↗
• InjuryJan 11, 2017Failure to Osseointegrate; Failure to Osseointegrate

  PATIENT WAS REVISED DUE TO LOOSENING OF ACETABULAR COMPONENT.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 6244214 ↗

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-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-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-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-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-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-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-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-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-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-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-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.