REVISION REVISION HIP - Ti6Al4V (REF 3810.15.010)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033390003841), received between Sep 14, 2020 and Jul 3, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2026Mechanical Problem

  INTRA OPERATIVE ISSUE OCCURRED ON (B)(6) 2026 DURING HIP SURGERY: THE SURGEON PREPARED THE FEMUR CANAL WITH THE REAMER REVISION - REAMER DIA. 13MM (CODE 9038.10.515, LOT UNKNOWN) AND IMPLANTED THE REVISION MOD. STEM Ø14MM (CODE 3810.15.010, LOT 2400816, STER. 2400048). THE STEM DID NOT STAY IN THE MEDULLARY CANAL (IT APPEARED TO BE SMALLER THAN THE RASP). A PROSTHESIS FROM A DIFFERENT MANUFACTURER WAS THEN IMPLANTED. DUE TO THIS ISSUE, THERE WERE 40 MINUTES OF DELAY TO COMPLETE THE SURGERY. THIS EVENT OCCURRED IN GERMANY.

  Patient problems: Insufficient Information

  MAUDE report 25704028 ↗
• InjuryJan 30, 2026Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  A HIP REVISION SURGERY WAS PERFORMED ON (B)(6) 2026, DUE TO IMPLANT DISLOCATION. ACCORDING TO THE SOURCE OF THE COMPLAINT, THE EVENT WAS ALSO ASSOCIATED WITH A LATERAL PERIPROSTHETIC FRACTURE OF UNKNOWN ORIGIN. DURING THE REVISION PROCEDURE, THE SURGEON GAINED ACCESS TO THE IMPLANT AND EXPLANTED THE STEM, NECK, HEAD, AND LINER. DUE TO THE UNIQUE ANATOMICAL CHARACTERISTICS OF THE PATIENT, A STANDARD CEMENTED STEM WAS DEEMED UNSUITABLE; THEREFORE, A LONG-CEMENTED STEM COMBINED WITH CABLING AROUND THE FRACTURE SITE WAS REQUIRED. THE SURGEON TRAILED THE LONG-CEMENTED STEM AND NECK WITH A DUAL MOBILITY LINER AND HEAD, CONFIRMING FIT AND POSITIONING THROUGH INTRA-OPERATIVE X-RAYS. ONCE SATISFACTORY POSITIONING WAS ACHIEVED, THE SURGEON PROCEEDED WITH CEMENTING THE LONG STEM AND CABLING THE FRACTURE SITE, FOLLOWED BY DEFINITIVE IMPLANTATION OF THE DUAL MOBILITY LINER AND HEAD. THE PREVIOUS SHOULDER SURGERY WAS PERFORMED 6 DAYS EARLIER (B)(6) 2026). THE FOLLOWING DEVICES WERE EXPLANTED IN THE PROCEDURE: REVISION MOD. STEM Ø14MM (PRODUCT CODE 3810.15.010, LOT # 2510118- STER. (B)(4), MOBILE LINER ØINT 28 MM Ø40 MM (PRODUCT CODE 5566.50.401, LOT # 25AT278- STER. (B)(4), REVISION LATER. NECK

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 24223081 ↗
• MalfunctionMay 5, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING A REVISION HIP STEM SURGERY, IT WAS REPORTED THAT THE SURGEON HAD TO CHANGE THE IMPLANT BECAUSE THE DIAMETER INDICATED ON THE INITIAL REVISION MOD. STEM Ø14MM (CODE: 3810.15.010, LOT: 2308645 - STER: (B)(4)) WAS TOO SMALL (NOT THE CORRECT DIAMETER) AND DID NOT FIT IN THE FEMUR. TO COMPLETE THE SURGERY THE SURGEON HAD TO IMPLANT ANOTHER HIP STEM - REVISION MOD. STEM Ø16MM (CODE: 381215010, LOT: 2323150 - STER. (B)(4)) - WITH A DIAMETER OF 16 MM AND A LENGTH OF 140 MM INSTEAD OF A HIP STEM WITH A DIAMETER OF 14 MM AND A LENGTH OF 140 MM, AS ORIGINALLY PLANNED. IT WAS REPORTED THAT THERE WAS A 10-MINUTE DELAY ON THE SURGERY. EVENT OCCURRED IN FRANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960316 ↗
• InjurySep 14, 2020Fracture

  FEMORAL BONE FRACTURE CONFIRMED 3 WEEKS AFTER SURGERY ON THE LATERAL PART OF THE CONNECTION AREA BETWEEN REVISION STEM AND NECK. NO TRAUMA, NO FALL REPORTED. REVISION SURGERY NOT PERFORMED YET. PREVIOUS SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2020 (NOT REPORTED TO LIMA CORPORATE). DURING PREVIOUS SURGERY THE FOLLOWING ITEMS WERE IMPLANTED: REVISION MOD. STEM Ø14MM (PRODUCT CODE 3810.15.010, LOT# 1611031 - STER.2000028), FEM. MODULAR HEAD - M Ø36MM (PRODUCT CODE 5010.42.362, LOT# 2081573 - STER.2000044), REVISION MODULAR NECK H.80MM (PRODUCT CODE 7515.15.030, LOT# 1918769 - STER.1900407). ACCORDING TO THE COMPLAINT SOURCE, THE STEM WAS IMPLANTED DEEPER THAN PLANNED. FURTHERMORE, THE PATIENT'S FEMORAL CANAL WAS VERY NARROW AND IT WAS NOT EASY TO REACH THE PRESCRIBED VALUE WITH THE REAMER: AS A MATTER OF FACT, THE REAMER WAS THICK FOR THE NARROW CANAL AND CONSEQUENTLY, CORTICAL BONE WAS SHARPENED RESULTING IN UNEVEN AREA. EVENT HAPPENED IN (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 10527488 ↗