DJO SURGICAL 430-98-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888912084048), received between Jun 8, 2017 and Jun 8, 2022 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2022Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY - PATIENT PRESENTED WITH WHAT APPEARED TO BE A LOOSENING ACETABULAR COMPONENT. SUCCESSFULLY EXPLANTED CUP, SCREWS, & LINER, & RE-IMPLANTED REDSPTNCUP/SCREWS, OR3O DM LINER, AND DJO 28MM CERAMIC HEAD.

  Patient problems: Insufficient Information

  MAUDE report 14634526 ↗
• InjuryDec 27, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - TOOK OUR LINER, HEAD AND CUP SCREW EXPERT PROXIMAL BODY.

  Patient problems: Insufficient Information

  MAUDE report 13090929 ↗
• InjuryMar 11, 2020Loose or Intermittent Connection; Failure to Align

  REPORTED INCIDENT - DURING SURGERY AFTER IMPLANTATION, SURGEON RAN HIP THROUGH RANGE OF MOTION AND NOTICED THAT THE CUP HAD COME LOOSE. ONCE THE CUP/LINER AND HEAD WAS EXPLANTED NOTICED THAT THE ARTICULATION BETWEEN THE HEAD AND THE LINER WAS OFF. UPON FURTHER INSPECTION NOTICED THAT THE LINER WAS IMPROPERLY SEATED. SURGEON BELIEVES THAT WAS THE CAUSE OF THE ARTICULATION ISSUE. HOWEVER WANTED IMPLANTS TO BE SENT IN FOR FURTHER INSPECTION TO CONFIRM THAT WAS THE CAUSE AND NOT A MANUFACTURING ISSUE.

  Patient problems: Loss of Range of Motion

  MAUDE report 9818562 ↗
• InjuryDec 19, 2019Unstable

  REVISION SURGERY - SURGEON AND PATIENT DECIDED TO REVISE ACETABULAR CUP FOR ADDITIONAL STABILITY.

  Patient problems: Failure of Implant

  MAUDE report 9495222 ↗
• InjuryDec 17, 2019Unintended Movement

  REVISION SURGERY - PATIENT HAD A BAD FALL. SURGEON CALLED REPORTER TO TELL HIM THAT THE SCREWS AND ACETABULAR CUP HAD MOVED.

  Patient problems: Fall

  MAUDE report 9481855 ↗
• InjuryJan 4, 2019Unstable

  REVISION SURGERY - DUE TO THE PATIENT HAVING INSTABILITY. THE SURGEON REPLACED THE HEAD; USED STRYKER PRODUCTS TO REPLACE THE SHELL AND LINER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8219967 ↗
• InjuryOct 5, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO THE PATIENT COMPLAINING OF PAIN IN THE RIGHT HIP JOINT. THE SURGEON REMOVED THE CUP AND THE LINER AND REPLACED WITH ANOTHER COMPANY'S CUP. HE ALSO REPLACED THE HEAD.

  Patient problems: Pain

  MAUDE report 7939674 ↗
• InjuryJun 7, 2018Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO A DISLOCATION. THE COMPONENTS WERE REVISED AFTER DISLOCATION IMMEDIATELY POST OPERATIVE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 7580139 ↗
• InjuryMay 16, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO THE PATIENT EXPERIENCING PAIN IN HIP. THE SURGEON REMOVED AND REPLACED ALL IMPLANTS EXCEPT FOR THE STEM.

  Patient problems: Pain

  MAUDE report 7519106 ↗
• MalfunctionApr 10, 2018Migration or Expulsion of Device

  REPORTED INCIDENT - ACETABULAR BONE SCREW APPEARED TO ADVANCE BEYOND THE CLUSTER HOLE OF THE FMP SHELL. THE SCREW WAS DRILLED USING THE FMP DRILL GUIDE, SHORT 3.3 MILLIMETER DRILL BIT, AND FMP DRILL BIT SHAFT. AN FMP DEPARTMENT GAUGE WAS USED TO MEASURE THE SCREW LENGTH AND THE 40 MILLIMETER SCREW WAS INSERTED BY HAND BY THE SURGEON. THE REAL LINER WAS THEN IMPACTED IN PLACE IN USUAL FASHION. UPON REVIEW OF THE INTRA OPERATIVE X-RAY FOR THE FEMORAL BROACH, IT WAS NOTICED THAT THE ACETABULAR BONE SCREW APPEARED TO HAVE ADVANCED FARTHER THAN THE BOTTOM OF THE SHELL.

  Patient problems: No Code Available

  MAUDE report 7419298 ↗
• InjuryAug 17, 2017Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY: DUE TO THE PATIENT EXPERIENCING PAIN.

  Patient problems: Pain

  MAUDE report 6802656 ↗
• InjuryJun 16, 2017Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO THE PATIENT HAVING DISLOCATED 3 WEEKS POST-OPERATION. THE SURGEON DECIDED TO REVISE THE ACETABULAR COMPONENTS TO CORRECT THE VERSION AND INCLINATION OF THE SHELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6648346 ↗
• InjuryJun 8, 2017Break

  ORIGINAL SURGERY - THE THREADS CAME OUT ON SHELL INTO THE INSERTER. THE OFFSET INSERTER BROKE FREE AND RIPPED THE THREADS OUT OF THE DOME, ITEM WAS LEFT IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6623017 ↗