Alexis ® Orthopaedic Protector HR004Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00607915123185), received between Sep 20, 2016 and Nov 8, 2024 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Material Perforation” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: THP ANTERIOR APPROACH. DESCRIPTION OF EVENT: COMPLAINT 1 OF 2: (B)(4) - MFR# 2027111-2024-00903. COMPLAINT 2 OF 2: (B)(4) - MFR# 2027111-2024-00896. THE ALEXIS ORTHOPEDIC WAS USED ACCORDING TO THE IFU. DURING THE PROCEDURE THE ALEXIS WAS PLACED ACCORDING TO THE IFU. DURING THE REAMING FASE OF THE FEMUR THE TOOTH OF THE REAMER CAUGHT UP ON THE ALEXIS SHEET. THIS HAPPENS ALMOST STANDARD IN THE PROCEDURE. THEORETICALLY FIBERS OF THE SHEET COULD COME IN CONTACT WITH THE REAMER/ FEMUR. DURING THE PROCEDURE THE ALEXIS WAS PLACED ACCORDING TO THE IFU. DURING THE REAMING PHASE OF THE FEMUR THE TOOTH OF THE REAMER CAUGHT UP ON THE ALEXIS SHEET. THIS HAPPENS IN 80% OF THE PROCEDURES. THEORETICALLY FIBERS OF THE SHEET COULD COME IN CONTACT WITH THE REAMER/ FEMUR. DUE TO THE ANGLE OF THE REAMER DURING THE ANTERIOR APPROACH IT'S LIKELY TO HAPPEN THE SHEET TEARS. THE TEAR IN THE SHEET FOR THE SURGEON IS NO PROBLEM. THE WOUND MARGINS ARE STILL VERY CLEAN. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA EMAIL ON 23OCT24: ATTACHED YOU WILL FIND THE PHOTOS OF CER1. BOTH DESCRIPTIONS ARE THE SAME AND BOTH HAPPENED AT THE SAME DAY AND PLACE. ONE ADJUSTMENT: I USED THE WORD R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20645713 ↗
• MalfunctionNov 7, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: THP ANTERIOR. DESCRIPTION OF EVENT: COMPLAINT 1 OF 2: (B)(4) - MFR# 2027111-2024-00903. COMPLAINT 2 OF 2: (B)(4) - MFR# 2027111-2024-00896. DURING THE PROCEDURE THE ALEXIS WAS PLACED ACCORDING TO THE IFU. DURING THE REAMING FASE OF THE FEMUR THE TOOTH OF THE REAMER CAUGHT UP ON THE ALEXIS SHEET. THIS HAPPENS IN 80% OF THE PROCEDURES. THEORETICALLY FIBERS OF THE SHEET COULD COME IN CONTACT WITH THE REAMER/ FEMUR. DUE TO THE ANGLE OF THE REAMER DURING THE ANTERIOR APPROACH IT'S LIKELY TO HAPPEN THE SHEET TEARS. THE SURGEON HAS NO PROBLEMS WITH THE TEAR IN THE ALEXIS. IT'S COMMON PRACTICE. IN 80% OF ALL CASES THIS HAPPENS. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA EMAIL ON 23OCT24: BOTH DESCRIPTIONS ARE THE SAME AND BOTH HAPPENED AT THE SAME DAY AND PLACE. ONE ADJUSTMENT: I USED THE WORD REAMER, BUT I MEANT BROACH IN THE DESCRIPTION OF THE CER. THE IMAGE IS A BROACH; USED TO WIDEN THE FEMUR FOR THE STEM PROSTHESIS. THE TEETH OF THE BROACH CATCH UP ON THE SHEET OF THE ALEXIS WHEN USED. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA EMAIL ON 30OCT24: NOT THAT PARTICULATE COULD BE SEEN, UNLESS IT¿S ON FIBER LEVEL, ALL MATERIAL WAS RETRIEVED. INTERV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20635122 ↗
• MalfunctionSep 1, 2023Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: TOTAL HIP ARTHROPLASTY : DIRECT ANTERIOR. DESCRIPTION OF EVENT: THE REP WAS NOT PRESENT FOR THE CASE. THE ALEXIS TORE DURING THE PROCEDURE INTO MULTIPLE PIECES. THE SURGEON NOTICED AT THE END OF THE CASE WHEN REMOVING THE DEVICE. THE SURGEON WAS ABLE TO RETRIEVE ALL THE FRAGMENTS. IT IS UNKNOWN HOW THE BAG TORE. THE MIDDLE OF THE ALEXIS SHEATH TORE AND RIPPED INTO LITTLE PIECES. NO TISSUE WAS BEING REMOVED. THE DEVICE WAS PLACED AROUND THE THIGH NEAR THE PELVIS ABOVE THE FEMUR IN A 4-5 CM INCISION. NO SPECIMEN WAS MANUALLY MORCELLATED FOR REMOVAL. PRODUCT IS NOT AVAILABLE FOR RETURN. TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH THE SAME DEVICE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671372 ↗
• InjuryMay 2, 2023Malposition of Device; Malposition of Device

  PROCEDURE PERFORMED: THA OCM. EVENT DESCRIPTION: [NAME] HOSPITAL. REPORT FROM FI. SAMPLE TRIALED IN 4/6 CASE. IT WAS INSERTED UNDER THE FASCIA AND USED. THIS CER IS NOT A COMPLAINT BUT A HEALTH HAZARD REPORT. ACUTE THROMBOTIC LOWER LIMB ARTERIAL OCCLUSION WAS OCCURRED, PROBABLY DURING AND IMMEDIATELY AFTER SURGERY. THE INCISION WAS ABOUT 8 CM. DURING RASPING, CONTACT WITH THE SHEATH OCCURRED, CAUSING A HOLE, BUT NO TEARING WAS OBSERVED. THERE WAS NO PARTICULAR IMPACT ON THE INTRAOPERATIVE OR OPERATIVE TIME. HE CONFIRMED THAT THE DEVICE WOULD NOT CAUSE ANY FRAGMENTS TO FALL INTO THE BODY, ALTHOUGH IT WOULD MAKE A HOLE IF HIT TOO HARD, AND CONTINUED TO USE IT. THE EVENT DEVICE WAS ALREADY DISCARDED BY HOSPITAL. ADDITIONAL INFORMATION RECEIVED ON APRIL 14TH, VIA EMAIL THE PATIENT IS CONSCIOUS AND HER LIFE IS NOT INDANGER INTERVENTION: THIS CER IS NOT A COMPLAINT BUT A HEALTH HAZARD REPORT. ACUTE THROMBOTIC LOWER LIMB ARTERIAL OCCLUSION WAS OCCURRED, PROBABLY DURING AND IMMEDIATELY AFTER SURGERY. PATIENT STATUS: THE PATIENT IS CONSCIOUS AND HER LIFE IS NOT INDANGER.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16856475 ↗
• MalfunctionMay 7, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE PERFORMED: THA. DESCRIPTION OF EVENT: [FACILITY]. ENGLISH VERSION OF CER: AFTER BROACHING ONCE OR TWICE FOR THA, ALEXIS WAS FOUND TO HAVE A HOLE. DOCTOR CONTINUED TO USE THE PRODUCT WITHOUT REPLACING IT UNTIL HE COMPLETED THE SURGERY. IT HAS BEEN CONFIRMED THAT NO FRAGMENTS OF ALEXIS REMAIN IN THE SURGICAL FIELD. THERE WAS NO IMPACT TO THE PATIENT. THE DOCTOR IN CHARGE IS THE 11TH CASE OF USING ALEXIS ORTHOPEDIC PROTECTOR. THE FACILITY RECOGNIZES THAT IF IT INTERFERES VIOLENTLY, A HOLE WILL OPEN, BUT THEY SEEM THAT IT HAS SOME DURABILITY. SINCE IT WAS EASILY DAMAGED THIS TIME, IT WAS CONFIRMED THAT IT WAS A MALFUNCTION. IT HAS BEEN ALMOST 1 WEEK SINCE THE SURGERY DATE FOR THE APPLIED SIDE TO OBTAIN THE INFORMATION THIS TIME. IT TOOK A LONG TIME TO GET INFORMATION FROM THE FACILITY TO THE AGENCY BECAUSE THERE SEEMED TO BE AN IN-HOSPITAL PROCESS. THE FACILITY IS REQUESTING AN INVESTIGATION REPORT FROM THE MANUFACTURER. THE DOCTOR IN CHARGE KNOWS THAT IT WILL TAKE SEVERAL MONTHS FOR THE REPORT FROM APPLIED TO COME OUT. ENGLISH TRANSLATION OF JAPANESE VERSION OF CER: AFTER BROACHING ONCE OR TWICE WITH THA, IT WAS FOUND THAT THERE WAS A HOLE. AFTER THAT, I CONTINUED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316711 ↗
• MalfunctionMar 12, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE BEING PERFORMED "THA ALS APPROACH WITH A 10 CM INCISION." DETAILED DESCRIPTION OF EVENT: COMPLAINT BASED ON FEEDBACK ID #1684. SUBMITTED 23FEB2021. HOSPITAL: [NAME], JAPAN "REPORT FROM [NAME]. USING HR004 IN FIRST CASE IN THIS HOSPITAL. PATIENT (FEMALE, THIN) IN SUPINE POSITION." "THE FIXATION OF THE INNER RING WAS POOR, AND THE ORTHOPEDIC SURGEON PUT IT ON AND TOOK IT OFF SEVERAL TIMES DURING THE OPERATION, BUT THE FIXATION OF THE VASTUS LATERALIS MUSCLE WAS NOT STABLE THROUGHOUT. THE OUTER RING WAS WRAPPED INSIDE. IMG_0147 THIS PHOTO IS INTRAOPERATIVE VIEW, METAL RETRACTORS ARE USED, BUT INNER-RING IS NOT STABLE. IMG_0158 THIS PHOTO IS THE INNER RING COMING OFF FROM ALEXIS ORTHO." PHOTOS HAVE BEEN ATTACHED TO THIS COMPLAINT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 26FEB2021 FROM [NAME]. CER FORM HAS BEEN PROVIDED. "PATIENT WAS OLD FEMALE. ANTERIOR LATERAL APPROACH AND SKIN INCISION WAS 10CM. ALEXIS INNER RING WAS PLACED BELOW THE VASTUS LATERALIS AND OUTER RING WAS ROLLED DOWN INWARD. INNER TING WAS NOT STABLE AT THE POSITION AND POPPED OUT. SURGEON COMMENTED INNER RING DID NOT FIT IN. METAL RETRACTOR WAS ALSO USED ALONG WITH ALEXIS." PRODUCT IS NOT AVAILAB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478129 ↗
• MalfunctionAug 22, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE BEING PERFORMED: TOTAL ANTERIOR HIP REPLACEMENT. DETAILED DESCRIPTION OF EVENT: THE SURGEON POINTED OUT THAT THE UNIT WAS TORN. THIS WAS NOTED ABOUT HALF WAY THROUGH THE CASE. THE SURGEON CONTINUED TO USE THE DEVICE AND COMPLETED THE CASE WITH THE SAME UNIT. THE SHEATH DID NOT PARTICULATE AND THERE WERE NO MISSING PIECES. THE REP WAS PRESENT FOR THE CASE. NO PATIENT INJURY OCCURRED AND THE DEVICE WAS DISCARDED AFTER THE CASE BY THE HOSPITAL. A PHOTOGRAPH IS AVAILABLE. PATIENT STATUS: NO PATIENT INJURY OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT. TYPE OF INTERVENTION: NO INTERVENTION WAS PERFORMED AND THE SURGEON FINISHED THE CASE WITH THE SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923687 ↗
• MalfunctionApr 14, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  TOTAL SHOULDER REPLACEMENT - THE SURGEON USED THE ALEXIS ORTHO FOR THE FIRST TIME ON THIS PATIENT. HE ONLY KEPT THE PRODUCT IN PLACE FOR APPROXIMATELY 5 MINUTES OF THE SURGERY. IT SLIPPED OUT ON ONE OCCASION AND HE REPOSITIONED IT IN PLACE BENEATH THE DELTOID AND THE PEC MAJOR. HE FOUND IT TO BE OBSTRUCTING HIS VIEW, SO HE DECIDED NOT TO CONTINUE USING IT ON THIS OCCASION AND PRODUCT REMAINED OUT FOR THE MAJORITY OF THE PROCEDURE. WHEN [THE TERRITORY MANAGER] MET THE SURGEON HE MENTIONED THAT A CORACOID PROCESS FRACTURE HAD OCCURRED TO THAT PATIENT. TYPE OF INTERVENTION - REMOVED ALEXIS ORTHO AND NOT USED FOR REMAINDER OF SURGERY. PATIENT STATUS - "THE CORACOID PROCESS FRACTURE WAS DISCOVERED AND TREATED POST SURGERY."

  Patient problems: Injury

  MAUDE report 6494211 ↗
• MalfunctionMar 8, 2017Material Perforation; Material Perforation

  PROCEDURE PERFORMED UNKNOWN - "ALEXIS ORTHO WAS PLACED IN NORMAL FASHION. WHEN PLACING THE CUP, THE INNER ALEXIS RING GOT IN BETWEEN THE BIOMET CUP AND THE ACETABULUM. THE ALEXIS SHEET SHOWED A LESION OF CIRCA 7 MM WHEN IT WAS REMOVED. ACCORDING TO SURGEON MOST LIKELY CAUSED BY SHARP EDGES OF THE CUP DURING THE IMPINGEMENT." PATIENT STATUS - OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6390203 ↗
• MalfunctionMar 4, 2017Material Perforation; Material Perforation

  PROCEDURE PERFORMED UNKNOWN - "THE ALEXIS TORE DURING THE PROCEDURE DURING THE HIP REPLACEMENT WHILE USING BASIC ORTHO INSTRUMENTATION. THIS WAS A TRIAL PRODUCT, NO REPLACEMENT OR CREDIT NEEDED." PATIENT STATUS - OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6378872 ↗
• MalfunctionNov 9, 2016Material Perforation; Material Perforation

  LATERAL HIP REPLACEMENT- "THE ALEXIS ORTHO WAS PLACED CORRECTLY, BUT DURING THE PROCEDURE SEVERAL TEARS STARTED TO SHOW IN THE SHEAT OF THE ALEXIS. THE TEARS VARIED FROM 2MM TO 2CM. THE TEARS STARTED TO SHOW AFTER TENSION WAS PUT ON THE SHEAT BY PLACING THE BIOMET CUP." PATIENT STATUS - "NO PATIENT INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6091294 ↗
• MalfunctionNov 9, 2016Material Perforation; Material Perforation

  LATERAL HIP REPLACEMENT- "THE ALEXIS ORTHO WAS PLACED CORRECTLY, BUT DURING THE PROCEDURE THERE WERE LITTLE TEARS IN THE SHEAT OF THE ALEXIS. THE TEARS VARIED FROM 2MM TO 2CM. THE TEARS STARTED TO SHOW AFTER THE BIOMET CUP HAD BEEN PLACED." PATIENT STATUS: "NO PATIENT INJURY".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6091292 ↗
• MalfunctionNov 9, 2016Material Perforation; Material Perforation

  LATERAL HIP REPLACEMENT- "THE ALEXIS ORTHO WAS PLACED CORRECTLY, BUT DURING THE PROCEDURE THERE WERE LITTLE TEARS IN THE SHEAT OF THE ALEXIS. THE TEARS VARIED FROM 2MM TO 2CM. THE TEARS STARTED TO SHOW AFTER THE BIOMET CUP HAD BEEN PLACED." PATIENT STATUS: "NO PATIENT INJURY".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6090729 ↗
• MalfunctionSep 20, 2016Material Perforation; Material Perforation

  DIRECT ANTERIOR HIP- "ALEXIS ORTHO MATERIAL WAS MINIMALLY TORN THROUGHOUT THE PROCEDURE WITH A SHREDDED EFFECT VERSUS A STRAIGHT EDGE TEAR. MULTIPLE USE OF THE TOOLS, PARTICULARLY THE RASPER APPEARED TO CONTRIBUTE TO THE MATERIAL BEING RIPPED. MULTIPLE METAL RETRACTORS WERE BEING USED AT THE TIME, HOWEVER, IT APPEARED THE TEARING EFFECT WAS CREATED BY CONTINUAL USE OF MULTIPLE INSTRUMENTS USED. DOCTOR WAS STILL HAPPY WITH PERFORMANCE OF ALEXIS ORTHO IN RELATION TO PROTECTING THE SKIN." TYPE OF INTERVENTION: REMOVAL OF ALL MATERIAL FROM PATIENT. PATIENT STATUS: NORMAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5965116 ↗