Torx 2030-6530-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07613327037005), received between Aug 10, 2017 and Jun 10, 2022 — classified as 12 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2022Corroded; Corroded

  LEFT HIP REVISION FOR PAIN, PSEUDO TUMOR, AND ELEVATED COBALT LEVELS. CUP, SCREWS, INSERT, AND HEAD WERE REVISED. COMPETITOR CUP, SCREWS, AND INSERT WERE USED ALONG WITH A STRYKER UNIVERSAL TAPER CERAMIC HEAD. UPDATE BASED ON MEDICAL REVIEW. THE PREOPERATIVE DIAGNOSES AND POSTOPERATIVE DIAGNOSES WERE THE SAME: "PSEUDO-TUMOR LEFT HIP FOLLOWING LEFT TOTAL HIP ARTHROPLASTY. COBALT AND CHROMIUM TOXICITY FOLLOWING LEFT TOTAL HIP ARTHROPLASTY. PAINFUL LEFT HIP. INSTABILITY/SUBLUXATION EVENTS FOLLOWING LEFT TOTAL HIP ARTHROPLASTY. CORROSION IDENTIFIED ON THE SHELL AT THE SCREW HOLES PER THE PROVIDED OP REPORT: "THROUGH THE HOLES ONE COULD SEE EXTENSIVE EVIDENCE FOR CORROSION MATERIAL THROUGH 3 OF THE 4 SCREW HOLES. THIS MATERIAL WAS BLACK AND SEEMED CONSISTENT WITH CORROSION".

  Patient problems: Foreign Body Reaction; Joint Laxity; Metal Related Pathology

  MAUDE report 14655839 ↗
• InjuryJun 10, 2022Corroded; Corroded

  LEFT HIP REVISION FOR PAIN, PSEUDO TUMOR, AND ELEVATED COBALT LEVELS. CUP, SCREWS, INSERT, AND HEAD WERE REVISED. COMPETITOR CUP, SCREWS, AND INSERT WERE USED ALONG WITH A STRYKER UNIVERSAL TAPER CERAMIC HEAD. UPDATE BASED ON MEDICAL REVIEW. THE PREOPERATIVE DIAGNOSES AND POSTOPERATIVE DIAGNOSES WERE THE SAME: "PSEUDO-TUMOR LEFT HIP FOLLOWING LEFT TOTAL HIP ARTHROPLASTY. COBALT AND CHROMIUM TOXICITY FOLLOWING LEFT TOTAL HIP ARTHROPLASTY. PAINFUL LEFT HIP. INSTABILITY/SUBLUXATION EVENTS FOLLOWING LEFT TOTAL HIP ARTHROPLASTY. CORROSION IDENTIFIED ON THE SHELL AT THE SCREW HOLES PER THE PROVIDED OP REPORT: "THROUGH THE HOLES ONE COULD SEE EXTENSIVE EVIDENCE FOR CORROSION MATERIAL THROUGH 3 OF THE 4 SCREW HOLES. THIS MATERIAL WAS BLACK AND SEEMED CONSISTENT WITH CORROSION."

  Patient problems: Foreign Body Reaction; Joint Laxity; Metal Related Pathology

  MAUDE report 14655766 ↗
• InjuryJun 15, 2020Malposition of Device; Malposition of Device

  DURING THA SURGERY, IT WAS CONFIRMED BY RADIOGRAPHY THAT TWO SCREWS PENETRATED THE INNER WALL OF THE ACETABULUM. HOWEVER, THE DOCTOR DID NOT MENTION ANYTHING AND THE OPERATION CONTINUED. AFTER THE OPERATION, THE PATIENT COMPLAINED OF PAIN IN THE AFFECTED AREA. THE SCREW THAT HAD PENETRATED MAY HAVE DAMAGED THE NERVE, AND A REVISION WAS PERFORMED IMMEDIATELY. THE LINER AND SCREW WERE REMOVED. ONE SCREW WAS FIXED AGAIN AT A DIFFERENT POSITION. AFTER THE OPERATION, THE PATIENT'S PAIN DISAPPEARED. LEFT SIDE.

  Patient problems: Injury; Pain

  MAUDE report 10152925 ↗
• InjuryJun 1, 2020Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; 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 TRITANIUM 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 (5/8/2020) THAT THE PATIENT REQUIRED A REVISION OF THE CUP.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 10105511 ↗
• InjuryApr 1, 2019Positioning Problem; Migration; Positioning Problem; Migration

  THIS PI IS FOR THE REVISED IMPLANTS. IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO THE SHELL SHIFTING AND BECOMING ANTEVERTED. SURGEON CONFIRMED SHIFTING BY COMPARING POST-OP X-RAYS FROM PRIMARY IMPLANT ON (B)(6) 2019 AND POST-OP X-RAYS IN (B)(6) 2019. POSSIBLE CAUSE OR CONTRIBUTOR TO SHELL SHIFTING WAS NOT REPORTED TO REP. A SHELL, 2 SCREWS, LINER, BIOLOX CERAMIC HEAD AND ACCOLADE II STEM WERE REVISED TO A TRIDENT TRITANIUM REVISION SHELL WITH 5 SCREWS, AN ADM/MDM LINER CONSTRUCT, LFIT V40 METAL HEAD, AND ACCOLADE II STEM. THERE ARE NO ALLEGATIONS AGAINST THE LINER, HEAD, OR STEM.

  Patient problems: Injury

  MAUDE report 8470311 ↗
• InjuryApr 1, 2019Positioning Problem; Migration; Positioning Problem; Migration

  THIS PI IS FOR THE REVISED IMPLANTS. IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO THE SHELL SHIFTING AND BECOMING ANTEVERTED. SURGEON CONFIRMED SHIFTING BY COMPARING POST-OP X-RAYS FROM PRIMARY IMPLANT ON (B)(6) 2019 AND POST-OP X-RAYS IN (B)(6) 2019. POSSIBLE CAUSE OR CONTRIBUTOR TO SHELL SHIFTING WAS NOT REPORTED TO REP. A SHELL, 2 SCREWS, LINER, BIOLOX CERAMIC HEAD AND ACCOLADE II STEM WERE REVISED TO A TRIDENT TRITANIUM REVISION SHELL WITH 5 SCREWS, AN ADM/MDM LINER CONSTRUCT, LFIT V40 METAL HEAD, AND ACCOLADE II STEM. THERE ARE NO ALLEGATIONS AGAINST THE LINER, HEAD, OR STEM.

  Patient problems: Injury

  MAUDE report 8470310 ↗
• 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.

  Patient problems: Injury

  MAUDE report 8443604 ↗
• InjuryDec 28, 2018Unstable; Unstable

  PATIENT HAD COMPLAINED OF SUBLUXATION AND GRINDING OF HIP JOINT THAT WAS REPLACED IN 2007. WHEN SURGEON OPERATED AND DISLOCATED THIS JOINT THE CERAMIC LINER WAS FOUND TO HAVE A WORN SUPERIOR ASPECT OF THE LINER. SURGEON PERFORMED AN ACETABULAR REVISION. THE WORN LINER WAS NOTICED INTRAOPERATIVELY, HOWEVER THE PATIENT HAD BEEN COMPLAINING OF INSTABILITY PREVIOUSLY.

  Patient problems: Injury

  MAUDE report 8204103 ↗
• InjuryDec 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD COMPLAINED OF SUBLUXATION AND GRINDING OF HIP JOINT THAT WAS REPLACED IN 2007. WHEN SURGEON OPERATED AND DISLOCATED THIS JOINT THE CERAMIC LINER WAS FOUND TO HAVE A WORN SUPERIOR ASPECT OF THE LINER. SURGEON PERFORMED AN ACETABULAR REVISION. THE WORN LINER WAS NOTICED INTRAOPERATIVELY, HOWEVER THE PATIENT HAD BEEN COMPLAINING OF INSTABILITY PREVIOUSLY.

  Patient problems: Injury

  MAUDE report 8204094 ↗
• InjurySep 10, 2018Break; Fracture; Break; Fracture

  IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PATIENT, AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY, "THE PATIENT RECEIVED A TRIDENT ACETABULAR HIP SYSTEM." IT WAS FURTHER ALLEGED THAT THE PATIENT IS EXPERIENCING, 'LOOSENING' FROM THE SYSTEM." UPDATED PER MEDICAL REVIEW: ¿ON (B)(6) 2011 A REVISION OF THE LEFT TOTAL HIP ARTHROPLASTY ACETABULAR COMPONENT WAS PERFORMED FOR A DIAGNOSIS OF FAILED ACETABULAR COMPONENT LEFT HIP. THE CUP WAS REMOVED WITHOUT MAJOR BONE LOSS AND DURING REMOVAL A BROKEN SCREW WAS NOTED, WHICH WAS RETRIEVED EXCEPT FOR A SMALL RETAINED TIP OF THE SCREW THAT REMAINED IN THE BONE. THE REPORT NOTES,"... BONE GRAFTING THE DEFICIT OF THE ACETABULUM", AND A 54MM CUP WITH TWO SCREWS WAS UTILIZED, ALONG WITH A 36/0° X3 INSERT, ALL BY UNCOMPLICATED SURGERY.¿

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7861893 ↗
• MalfunctionAug 16, 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 7788731 ↗
• MalfunctionJul 10, 2018Break; Crack; Fracture; Break; Crack; Fracture

  THE HEAD OF A 30MM TORX SCREW CAME OFF WHILST IT WAS BEING IMPLANTED. THE SCREW BODY WAS IMPLANTED WHEN THE HEAD BROKE. THE EXPOSED SECTION OF THE SCREW WAS BURRED DOWN, AS NOT TO PROTRUDE FROM THE CUP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7674929 ↗
• InjuryJun 28, 2018Break; Fracture; Loss of Osseointegration; Break; Fracture; Loss of Osseointegration

  IT WAS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LAWSUIT, THAT THE PLAINTIFF UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015 WHERE SHE WAS IMPLANTED WITH A STRYKER SECUR-FIT MAX SYSTEM. IT IS FURTHER ALLEGED THAT "IN THE SPRING OF 2016, PLAINTIFF BEGAN EXPERIENCING EXTREME PAIN AND DISCOMFORT IN HER LOWER BACK AND RIGHT HIP. SHE HAD DIFFICULTY WALKING AND REQUIRED THE USE OF A CRUTCH TO GET AROUND". THE PATIENT'S RIGHT HIP WAS THEN REVISED ON (B)(6) 2016. DR. (B)(6) STATED IN HIS OPERATIVE REPORT THAT "ONE OF THE SCREW HEAD [SIC] WAS BROKEN AND WAS REMOVED AND THEN THE CUP REMOVED". DR. (B)(6) ALSO NOTED THAT AN "ADDITIONAL BROKEN SCREW WAS REMOVED USING HAND INSTRUMENTS".

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Inadequate Osseointegration; Injury; Pain

  MAUDE report 7645715 ↗
• MalfunctionApr 30, 2018Packaging Problem; Packaging Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7474856 ↗
• InjuryJan 5, 2018Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. INTRA-OPERATIVELY, THE SURGEON REPORTED THAT THE 30MM SCREW WAS BROKEN. PATIENT WAS REVISED TO AN MDM CONSTRUCT. A MEDICAL REVIEW BY CLINICAL CONSULTANT STATES "CUP MALPOSITION IN MEDIALIZED POSITION WITH ADDITIONAL ADVERSE SHORT LEG LENGTH EFFECTS HAS CONTRIBUTED TO AN OVERLOAD CONDITION IN THE ARTHROPLASTY CONTRIBUTING TO CUP LOOSENING REQUIRING REVISION."

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain

  MAUDE report 7167968 ↗
• MalfunctionNov 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  SALES REP REPORTED DURING PRIMARY HIP SURGERY, SURGEON HAD DIFFICULTY GETTING THREE SCREWS TO GO IN CUP; SURGEON OPENED NEW SCREWS TO COMPLETE SURGERY. THERE WAS A 15 - 20 MINUTE DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7071985 ↗
• MalfunctionNov 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  SALES REP REPORTED DURING PRIMARY HIP SURGERY, SURGEON HAD DIFFICULTY GETTING THREE SCREWS TO GO IN CUP; SURGEON OPENED NEW SCREWS TO COMPLETE SURGERY. THERE WAS A 15 - 20 MINUTE DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7071983 ↗
• MalfunctionAug 10, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PLACED A TRIDENT HEMISPHERICAL ACETABULAR CUP AND INSERTED A 6.5 TORX BONE SCREW AND SCREW WENT THROUGH THE CUP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6786312 ↗

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-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-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-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-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-2133-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics 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 optional fixt
• 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
• 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-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-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-2137-2009 · Jun 26, 2009 · Terminated
  Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 30 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

…and 17 more.