Alexis® Orthopaedic Protector HR104Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00607915138950), received between Apr 24, 2024 and Feb 20, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: PTH VOIE ANTERIEUR. EVENT DESCRIPTION: THE ALEXIS WAS IN POSITION, AFTER USING THE SHARP TOOLS LIKE THE RASP, THE ALEXIS TEARED FROM THE SIDE. THE PATIENT WAS OBESE, SO ADDITIONAL FORCES WAS NEEDED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA 30JAN25: THE PATIENT'S STATUS IS GOOD, NO IMPACT WHATSOEVER, AND NO INJURY. INTERVENTION: NO ADDITIONAL INTERVENTION WAS NEEDED. PATIENT STATUS: THE PATIENT'S STATUS IS GOOD, NO IMPACT WHATSOEVER, AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21426704 ↗
• MalfunctionJul 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: ANTERIOR HIP ARTHROPLASTY. DESCRIPTION OF EVENT: COMPLAINT 1 OF 3: (B)(4) - MFR# 2027111-2024-00706; COMPLAINT 2 OF 3: (B)(4); COMPLAINT 3 OF 3: (B)(4). ANTERIOR HIP ARTHROPLASTY. THE ALEXIS ORTHO WAS PLACED ACCORDING TO THE IFU UNDER THE TFL AND THE SARTORIUS. AFTER REMOVING THE ALEXIS ORTHO AT THE END OF THE PROCEDURE, THERE WAS A TEAR IN THE SHEATH OF THE ALEXIS ORTHO. PRODUCT TEST WITH (NAME REDACTED) FOR AN ANTERIOR HIP ARTHROPLASTY AT [FACILITY] IN [CITY]. THE SURGEON FINISHED THE SURGERY WITHOUT COMPLICATIONS. THE TEAR IN THE SHEATH WAS FIRST DISCOVERED AFTER THE SURGERY. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA E-MAIL ON 19JUN2024: THE MALFUNCTION OCCURRED IN THE MIDDLE OF THE OR WHILE INTRODUCING THE ACETABULAR SOCKET IN TO THE PELVIC. THE REGULAR INSTRUMENTS USED FOR ANTERIOR HIP ARTHROPLASTIES WERE USED DURING THIS PROCEDURE TOGETHER WITH THE ALEXIS WERE BREACHER, REAMER, RETRACTORS. THE INSTRUMENTS WERE USED AS NORMAL DURING ANTERIOR HIP ARTHROPLASTIES. WE ARE NOT SURE IF THE DEVICE PARTICULATED, THE SURGEON MEANT THAT THE ALEXIS PARTICULATED AND PART OF THE ALEXIS SHEATH WAS NOW IMPLANTED ON THE ACETABULAR SOCKET. BUT THIS WAS JUST HIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19671622 ↗
• MalfunctionJun 21, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: ANTERIOR HIP ARTHROPLASTY. DESCRIPTION OF EVENT: COMPLAINT 1 OF 3: (B)(4) - MFR# 2027111-2024-00706. COMPLAINT 2 OF 3: (B)(4) - MFR# 2027111-2024-00728. COMPLAINT 3 OF 3: (B)(4) - MFR# 2027111-2024-00726. THE ALEXIS ORTHO WAS PLACED ACCORDING TO THE IFU UNDER THE TFL AND THE SARTORIUS. DURING THE PROCEDURE, WHILE INTRODUCING THE ACETABULAR CUP, THE SURGEON GOT IN CONTACT WITH THE SHEATH OF THE ALEXIS WHICH CAUSED A TEAR IN THE PRODUCT. PRODUCT TEST WITH (NAME REDACTED) FOR AN ANTERIOR HIP ARTHROPLASTY AT [FACILITY] IN ZÜRICH. THE SURGEON CONTINUED AND FINISHED THE PROCEDURE ACCORDINGLY WITHOUT ANY COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA E-MAIL ON 19JUN24: THE PATIENT IS FINE. THE MALFUNCTION OCCURRED IN THE MIDDLE OF THE OR WHILE INTRODUCING THE ACETABULAR SOCKET IN TO THE PELVIC. THE REGULAR INSTRUMENTS USED FOR ANTERIOR HIP ARTHROPLASTIES WERE USED DURING THIS PROCEDURE TOGETHER WITH THE ALEXIS BREACHER, REAMER, RETRACTORS, THE INSTRUMENTS WERE USED AS NORMAL DURING ANTERIOR HIP ARTHROPLASTIES WE ARE NOT SURE. THE SURGEON MEANT THAT THE ALEXIS PARTICULATED AND PART OF THE ALEXIS SHEATH WAS NOW IMPLANTED ON THE ACETABULAR SOCKET. B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19586998 ↗
• MalfunctionApr 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: TOTAL HIP ARTHROPLASTY. DESCRIPTION OF EVENT: [NAME] HOSPITAL. THIS IS A COMPLAINT FROM THE MARKET. REPORT FROM THE SALES REP. WHEN USING A REAMER, IT HIT THE PROTECTOR AND TORE THE SHEATH. CLINICAL SAMPLE AND NOT ACCUSTOMED TO USING THE PROTECTOR. SO, REAMER HIT IT. THIS UNIT WILL NOT BE RETURNED. DISCARDED AT HOSPITAL DUE TO INFECTION (HBS ANTIGEN +). TYPE OF INTERVENTION: THE PRODUCT WAS REMOVED AND SURGERY CONTINUED. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177276 ↗
• MalfunctionApr 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: THA. DESCRIPTION OF EVENT: (B)(6) HOSPITAL. THIS IS A COMPLAINT FROM THE MARKET. REPORT FROM THE SALES REP VIA EMAIL; THE SEAM OF THE ALEXIS SHEATH RIPPED SEVERAL CENTIMETERS. THE SURGEON NOTICED THAT THE SHEATH WAS RIPPED WHEN HE REMOVED IT. NO OTHER INSTRUMENTS ARE IN CONTACT WITH THE SHEATH. SEE ATTACHED FOR A PHOTO OF THE SHEATH TEAR. THIS UNIT WILL NOT BE RETURNED. TYPE OF INTERVENTION: NA. PATIENT STATUS: NO IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176054 ↗
• MalfunctionApr 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: THA. DESCRIPTION OF EVENT: [NAME] HOSPITAL. THIS IS A COMPLAINT FROM THE MARKET. REPORT FROM THE SALES REP VIA EMAIL; THE SEAM OF THE ALEXIS SHEATH RIPPED SEVERAL CENTIMETERS. THE SURGEON NOTICED THAT THE SHEATH WAS RIPPED WHEN HE REMOVED IT. NO OTHER INSTRUMENTS ARE IN CONTACT WITH THE SHEATH. SEE ATTACHED FOR A PHOTO OF THE SHEATH TEAR. THIS UNIT WILL NOT BE RETURNED. TYPE OF INTERVENTION: NA. PATIENT STATUS: NO IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176044 ↗