NA 112230Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00848486002923), received between Aug 6, 2018 and Dec 2, 2019 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Break” (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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2019Mechanical Problem; Premature Separation; Mechanical Problem; Premature Separation

  WHEN IMPACTING THE VIZADISC POPPED OFF THE ARRAY (SUPERIOR, RIGHT PEG WHEN LOOKING AT IT FROM THE BACK). THE DISC WAS FULLY SEATED. WHEN INSPECTING THE ARRAY AFTER THE CASE, THE DISC DOESN¿T STAY ON THE LEG TIGHT (IT EASY PULLS OFF COMPARED TO OTHERS). CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9396899 ↗
• MalfunctionDec 2, 2019Mechanical Problem; Misassembly by Users; Mechanical Problem; Misassembly by Users

  PELVIC ARRAY AND PELVIC ARRAY CLAMP GOT CROSS THREADED AND NEED TO BE REPLACED. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9396720 ↗
• MalfunctionDec 2, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  BROKEN PELVIC ARRAY WHEN TIGHTENING. CASE TYPE: THA. SURGICAL DELAY: 2 MINUTES. PATIENT WAS UNDER ANESTHESIA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9396713 ↗
• MalfunctionNov 26, 2019Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  PELVIC ARRAY IS BROKEN, COULDN¿T SCREW ONTO PIN CLAMP. CASE TYPE: TKA. SURGICAL DELAY <= 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9376885 ↗
• MalfunctionNov 22, 2019Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  WHILE ATTACHING THE HIP ARRAY THE INSIDE SCREW BROKE. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9362281 ↗
• MalfunctionOct 1, 2019Break; Fracture; Break; Fracture

  BROKE WHILE TIGHTENING. CASE TYPE: THA. SURGICAL DELAY: X <= 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9140209 ↗
• MalfunctionSep 11, 2019Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  ONE OF THE MEDAL ¿SPOKES¿ THAT VISZADISC ATTACHES BROKE OFF THE PELVIC ARRAY. CASE TYPE: THA. UPDATE: "WAS THE PATIENT UNDER ANESTHESIA? YES. NO INVOLVEMENT. WAS THERE PATIENT INVOLVEMENT? ANY PATIENT HARM? STATE ANY ADVERSE CONSEQUENCES. NO PATIENT HARM. NO INVOLVEMENT".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8995350 ↗
• MalfunctionAug 9, 2019Break; Fracture; Break; Fracture

  ARRAY CLAMP AND ARRAY BROKE WHEN TIGHTENING. CASE TYPE: THA. SURGICAL DELAY: 2 MINUTES. UPDATE: "PATIENT WAS UNDER ANESTHESIA, IT HAPPENED INTRA OP. NO PARTS OF THE DEVICE WERE MISSING BEFORE THIS HAPPENED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8878867 ↗
• MalfunctionAug 7, 2019Detachment of Device or Device Component; Premature Separation; Detachment of Device or Device Component; Premature Separation

  DURING IMPACTION THE VIZADISC KEPT POPPING OFF ONE OF THE PELVIC ARRAY PEGS THAT SECURES THE VIZADISC. IT WAS DETERMINED AFTER THE CASE THAT THE PEG THAT SECURES THE VIZADISC WAS DAMAGED AFTER ATTEMPTING TO PUT ANOTHER VIZADISC ON THE ARRAY AND NOT BEING ABLE TO KEEP IT SECURE TO THE ARRAY. CASE TYPE: THA. UPDATE: NO DEBRIS/COMPONENTS LEFT IN PATIENT. NO COMPONENTS OF THE DEVICE MISSING OR DISASSEMBLED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8871208 ↗
• MalfunctionAug 2, 2019Material Integrity Problem; Premature Separation; Material Integrity Problem; Premature Separation

  THE VIZADISCS POP OFF THE ARRAY WHEN IMPACTING THE CUP.... THIS HAS OCCURRED PREVIOUSLY AND WERE PLACED BACK ON TO FINISH CASES. DR (B)(6) ASKED THAT I HAVE THE ARRAY REPLACED NOW THAT IS HAS REOCCURRED. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8858167 ↗
• MalfunctionMay 30, 2019Detachment of Device or Device Component; Non Reproducible Results; Detachment of Device or Device Component; Non Reproducible Results

  SCREW SNAPPED ON PELVIC ARRAY WHILE TIGHTENING. PICTURES AVAILABLE IF NEEDED. CASE TYPE: THA. SURGICAL DELAY: 15 MINUTES. UPDATE: "YES THE PATIENT WAS UNDER ANESTHESIA BUT THERE WAS NO PATIENT INVOLVEMENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8654151 ↗
• MalfunctionApr 4, 2019Detachment of Device or Device Component; Non Reproducible Results; Detachment of Device or Device Component; Non Reproducible Results

  PELVIC ARRAY'S LOWER PEG HAD IT'S VISADISC ALLOWED TO BE TOO LOSE/COMING FREE WITH IMPACTION. DR. WAS HAPPY WITH HIS CUP PLACEMENT AND REST OF THE CASE BUT DID NOT BELIEVE THE LEG LENGTH NUMBERS TO BE TOTALLY ACCURATE. CASE TYPE: THA. WHAT IS THE ESTIMATED DISCREPANCY IN ACCURACY REGARDING THE LEG LENGTH NUMBERS? CAN YOU QUANTIFY THE GAP IN LENGTH? WAS THERE A DISCREPANCY BETWEEN PLANNED VS OUTCOME? AS PER THE MPS: THE DR. WAS CONTENT WITH THE PLACEMENT OF THE CUP AND DID NOT WORK ABOUT HIS LENGTH/OFFSET NUMBERS. I COULD CHECK WHAT THE PLANNED OUTCOME WAS ON MONDAY 4/1, BUT I DON'T HAVE ANY REAL DATA FOR YOU ON HOW MUCH OF A DISCREPANCY THERE WAS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8485734 ↗
• MalfunctionMar 4, 2019Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  BROKEN CLAMP ON PELVIC ARRAY WHEN TIGHTENING. CASE TYPE: (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8387244 ↗
• MalfunctionFeb 21, 2019Detachment of Device or Device Component; Non Reproducible Results; Detachment of Device or Device Component; Non Reproducible Results

  VISADISC DETACHED FROM BOTTOM RIGHT PEG OF PELVIC ARRAY DURING IMPACTION. THIS HAPPENED ON MULTIPLE OCCASIONS WITH IMPACTION. EVENTUALLY, TRIED A DIFFERENT VISADISC AND ISSUE CONTINUED TO OCCUR. AFTER INSPECTION, VISADISCS SEEMED TO COME OFF OF THAT PARTICULAR PEG EASIER THAN OTHERS. CASSE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8358265 ↗
• MalfunctionJan 31, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  WHILE TIGHTENING THE ARRAY THE SCREW BROKE. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8294478 ↗
• MalfunctionJan 7, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  THA. EVENT DESCRIPTION: THE SCREW THAT TIGHTENS THE PELVIC ARRAY TO THE PELVIC ARRAY CLAMP BROKE. SURGICAL DELAY 4 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8221617 ↗
• MalfunctionDec 27, 2018Detachment of Device or Device Component; Non Reproducible Results; Detachment of Device or Device Component; Non Reproducible Results

  WHILE IMPACTING THE CUP A VIZADISC FLEW OFF OF THE PELVIC ARRAY. WE REPLACED THE VIZADISC AND MADE SURE IT SECURELY SNAPPED ON TO THE PEG ON THE ARRAY. IMPACTED AGAIN, SAME THING HAPPENED, SAME VIZADISC FLEW OFF. THIS HAPPENED MULTIPLE TIMES. SURGICAL DELAY- =15 MINUTES. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8200163 ↗
• MalfunctionNov 2, 2018Break; Material Integrity Problem; Break; Material Integrity Problem

  DOCTOR (B)(6) WAS TIGHTENING THE PELVIC ARRAY ONTO THE 2-DOF CLAMP AND THE NUT BROKE OFF OF THE PELVIC ARRAY. INCISION/EXPOSURE HAD NOT BEEN DONE YET. ALL PIECES WERE RETRIEVED AND TAKEN OFF THE FIELD. WE WERE ABLE TO PROCEED WITH A NEW PELVIC ARRAY. SURGICAL DELAY=15 MINUTES. CASE TYPE: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8033032 ↗
• MalfunctionOct 30, 2018Break; Fracture; Break; Fracture

  PELVIC ARRAY SCREW BROKE OFF. SURGICAL DELAY - =15 MINUTES. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8020240 ↗
• MalfunctionOct 15, 2018Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  DURING TIGHTENING OF THE ARRAY, THE BOLT SHEARED OFF. SURGICAL DELAY - =15 MINUTES. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7965592 ↗
• MalfunctionSep 28, 2018Break; Detachment of Device or Device Component; Non Reproducible Results; Break; Detachment of Device or Device Component; Non Reproducible Results

  ATTACHMENT SCREW PELVIC ARRAY MAKO THA BROKE DUE TO WEAR AND HIGH FORCES. OPENED NEW THA ARRAY KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 7920117 ↗
• MalfunctionAug 6, 2018Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  BROKEN SCREW PELVIC ARRAY. THE SET IS HEAVILY USED AND THE SURGEON USES A LOT OF FORCE TIGHTENING THE SCREW. ANOTHER PELVIC ARRAY WAS AVAILABLE TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7754404 ↗