Alexis Orthopaedic ProtectorRecalls & reported problems across all models

We found 4 models of Alexis Orthopaedic Protector by Applied Medical Resources Corporation in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Sep 20, 2016 and Feb 25, 2025 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Alexis Orthopaedic Protector problems

Alexis Orthopaedic Protector models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Alexis ® Orthopaedic Protector HR004

  Ring (Wound Protector), Drape Retention, Internal
  14 reports
• Alexis® Orthopaedic Protector HR104

  Ring (Wound Protector), Drape Retention, Internal
  6 reports
• Alexis® Orthopaedic Protector HR105

  Ring (Wound Protector), Drape Retention, Internal
  2 reports
• Alexis ® Orthopaedic Protector HR005

  Ring (Wound Protector), Drape Retention, Internal
  1 report

Recent Alexis Orthopaedic Protector adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Delivered as Unsterile Product; Product Quality Problem; Delivered as Unsterile Product; Product Quality Problem

  NAME OF PROCEDURE BEING PERFORMED: TOTAL HIP ARTHROPLASTY - DIRECT ANTERIOR. DETAILED DESCRIPTION OF EVENT: AS AN UPDATE, WE ASKED FIELD LEADERSHIP TO REACH OUT TO THE ORTHO TEAM TO SEE IF THEY HAD ANY OUTSTANDING SCRUB FORMS THEY HAVE NOT TURNED INTO FIELD OPERATIONS FOR PROCESSING. AT THIS TIME, WE DISCOVERED AN ADDITIONAL SCRUB FORM FOR LOT# 1476912. I HAVE ATTACHED A COPY OF THE FORM FOR REFERENCE. IN ADDITION, THE ORTHO TEAM TAKES A PICTURE OF THE PRODUCT THEY ARE SCRUBBING IN TO ENSURE ACCURACY FOR THE POS. I HAVE ATTACHED THE IMAGE ASSOCIATED WITH THIS SCRUB FORM. PLEASE ME KNOW IF I CAN FURTHER ASSIST. ADDITIONAL INFORMATION OBTAINED FROM [NAME] (APPLIED MEDICAL FILED OPERATIONS MANAGER) VIA EMAIL ON 21FEB2025: YES, THIS DEVICE WAS USED IN A PROCEDURE. WE HAVE NOT HEARD OF ANY INJURY OR ILLNESS AT THIS TIME. I ALSO CONFIRMED THAT WHEN THE PRODUCT WAS PLACED, THE SURGEON IMMEDIATELY DETERMINED IT WAS THE WRONG SIZE AND IT WAS REMOVED. ADDITIONAL INFORMATION OBTAINED FROM [NAME] (APPLIED MEDICAL FILED OPERATIONS MANAGER) VIA EMAIL ON 25FEB2025: THE HR105 WAS REMOVED IMMEDIATELY SINCE THE INNER RING WAS TOO LARGE. TO MY KNOWLEDGE, NO OTHER SCRUB DEVICES WERE USED IN THE SAME P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21463106 ↗
• MalfunctionFeb 21, 2025Delivered as Unsterile Product; Product Quality Problem; Delivered as Unsterile Product; Product Quality Problem

  NAME OF PROCEDURE BEING PERFORMED: COMPLEX THA REVISION. DETAILED DESCRIPTION OF EVENT: ON 1/29/25, WE RECEIVED A SCRUB PO FROM [NAME] FOR 1 EA HR105, LOT# 1476912. THIS WAS SCRUBBED IN FOR NO CHARGE AT [FACILITY] ON (B)(6) 2024 (ATTACHED). [NAME] NOTED THIS WAS FOR A COMPLEX THA REVISION BUT WAS NOT A SUCCESSFUL CASE, WHICH IS WHY SHE SCRUBBED IT IN FOR NO CHARGE. WHEN REVIEWING THE LOT NUMBER, WE DETERMINED THIS PRODUCT WAS NOT SENT TO [NAME]. WE ALSO DETERMINED THERE WAS NO RECORD OF THIS LOT NUMBER BEING SENT TO ANY FIELD TEAM MEMBER OR CUSTOMER. THERE WAS NO PRODUCTION HISTORY, WHICH PROMPTED US TO CHECK THE SHOP ORDER IN SAP. AFTER LOOKING UP THE SHOP ORDER, WE DETERMINED THE LOT WAS FROM AN ENGINEERING SHOP ORDER AND WAS NOT RELEASED INTO FINISHED GOODS. PER THE ATTACHED COPY, THE PURPOSE OF THE SHOP ORDER IS ¿TO BUILD UNITS FOR REAL-TIME AGING AND TESTING PER REAL-TIME AGING PROTOCOL DIR # [NUMBER].¿ WE HAVE REACHED OUT TO THE ENG TEAM TO DETERMINE WHAT HAPPENED TO THESE UNITS AND HOPEFULLY TRACE DOWN HOW [NAME] WAS ABLE TO OBTAIN ONE (EMAIL ATTACHED). WE ALSO CHECKED THE CLASSIFICATION T-CODE FOR THIS LOT, AND SAW IT IS NOT US APPROVED AND THERE IS NO STERILIZATION DATE. D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21440052 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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