Hip InstrumentsRecalls & reported problems across all models
Medacta International SA · 48 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 91
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls
- 0
We found 48 models of Hip Instruments by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 91 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2018 and Sep 9, 2026 — classified as 32 injuries, 59 malfunctions.
The most frequently reported specific device problem is “Break” (23 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
Reports received per month, all models
Most reported Hip Instruments problems
Device problems
- Break23
- Fracture15
- Adverse Event Without Identified Device or Use Problem14
- Material Fragmentation10
- Appropriate Device Problem Term/Code Not Available9
- Detachment of Device or Device Component4
- Device Fell2
- Difficult to Remove2
Patient problems
- No Known Impact Or Consequence To Patient35
- Bone Fracture(s)26
- No Clinical Signs, Symptoms or Conditions15
- Insufficient Information4
- Foreign Body In Patient2
- Hip Fracture2
- No Consequences Or Impact To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Hip Instruments models
48 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Hip Instruments 01.10.10.130Orthopedic Manual Surgical Instrument10 reports
- Hip Instruments 01.10.10.131Orthopedic Manual Surgical Instrument10 reports
- Hip Instruments 01.15.10.0190Table, Operating-Room, Mechanical8 reports
- Hip Instruments 01.15.10.0131Orthopedic Manual Surgical Instrument5 reports
- HIP Instruments 01.15.10.0263Orthopedic Manual Surgical Instrument3 reports
- HIP Instruments 01.15.10.0315Table, Operating-Room, Mechanical3 reports
- Hip Instruments 01.18.10.102Orthopedic Manual Surgical Instrument3 reports
- Hip Instruments 01.32.10.1156Orthopedic Manual Surgical Instrument3 reports
- HIP Instruments 01.39.10.0033Orthopedic Manual Surgical Instrument3 reports
- HIP Instruments 01.15.10.0133Orthopedic Manual Surgical Instrument2 reports
- HIP Instruments 01.22.10.0109Orthopedic Manual Surgical Instrument2 reports
- HIP Instruments 01.22.10.0151Orthopedic Manual Surgical Instrument2 reports
- Hip Instruments 01.10.10.190Orthopedic Manual Surgical Instrument2 reports
- Hip Instruments 01.15.10.0321Table, Operating-Room, Mechanical1 report
- Hip Instruments 01.15.10.0041Orthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.15.10.0071Table, Operating-Room, Mechanical1 report
- Hip Instruments 01.15.10.0084Orthopedic Manual Surgical Instrument1 report
- HIP Instruments 01.15.10.0146Orthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.15.10.0261Orthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.08.10.0001Orthopedic Manual Surgical Instrument1 report
- HIP Instruments 01.22.10.0117Orthopedic Manual Surgical Instrument1 report
- HIP Instruments 01.22.10.0134Orthopedic Manual Surgical Instrument1 report
- HIP Instruments 01.22.10.0143Orthopedic Manual Surgical Instrument1 report
- HIP Instruments 01.22.10.0156Orthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.10.10.003Orthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.32.10.0114Orthopedic Manual Surgical Instrument1 report
- HIP Instruments 01.18.10.412Orthopedic Manual Surgical Instrument1 report
- HIP Instruments 01.18.10.415Orthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.32.10.0006Orthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.10.10.140Orthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.26.10.0162Orthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.10.10.018Orthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.18.10.099Orthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.18.10.104Orthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.18.10.207Orthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.32.10.1070Orthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.32.10.1154Orthopedic Manual Surgical Instrument1 report
- HIP Instruments 01.32.10.1158Orthopedic Manual Surgical Instrument1 report
- HIP Instruments 01.32.10.1400Orthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.20.10.100Orthopedic Manual Surgical Instrument1 report
- HIP Instruments 01.39.10.0031Orthopedic Manual Surgical Instrument1 report
- HIP Instruments 01.39.10.0034Orthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.26.10.0062Orthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.13.10.1102ROrthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.15.10.0690Orthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.26.10.0314Orthopedic Manual Surgical Instrument1 report
- Hip Instruments 01.26.10.0317Orthopedic Manual Surgical Instrument1 report
- HIP Instruments 01.10.10.0845Orthopedic Manual Surgical Instrument1 report
Recent Hip Instruments adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Detachment of Device or Device Component
During a total hip arthroplasty, an Mpact Double Mobility Cup was implanted using impaction handle 01.32.10.1070 with the dedicated impaction plate. During impaction of the final cup, while the cup was still engaged with the impactor, the anvil of the impaction handle became loose and detached, falling onto the operating room floor. As the cup was already positioned in the acetabulum, the surgeon completed the impaction using the same handle without the anvil. The central rod was also removed, and the impaction plate was disengaged from the cup using pliers. The cup was successfully implanted; however, the impaction handle was damaged and could no longer be used. The event resulted in an approximately 30-minute surgical delay, with a total surgery time of 130 minutes.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692273 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
DURING SURGERY, WHILE REAMING THE CALCAR FOR THE AMISTEM-P COLLARED IMPLANT SIZE 7, A FISSURE OCCURRED IN THE CALCAR. A CERCLAGE CABLE WAS APPLIED, AND A CEMENTED AMISTEM-C SIZE 6 WAS IMPLANTED AS THE FINAL SOLUTION. THE SURGERY WAS PROLONGED BY APPROXIMATELY 15 MINUTES DUE TO THE FIXATION OF THE FRACTURE. THE PATIENT HAD A DORR-C FEMUR WITH POOR BONE QUALITY.
Patient problems: Bone Fracture(s)
MAUDE report 24518514 ↗InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PLANNED STEM WAS A SIZE 3 STANDARD QUADRA P CEMENTED. POSTERIOR APPROACH USED. ALTHOUGH THE FEMUR WAS PREPARED TO SIZE 3 AND TRIALED WITH A 36 S HEAD, THE HIP COULD NOT BE REDUCED. THIS WAS UNEXPECTED, AS THE PLANNED OFFSET AND LEG LENGTH CHANGES WERE MINIMAL, AND INTRAOPERATIVE CHECKS SUGGESTED THE STEM WAS POSITIONED AS INTENDED. DOWNSIZING TO A SIZE 2 STILL DID NOT ALLOW REDUCTION. AS SHORT-NECK STEMS WERE NOT AVAILABLE, A SIZE 1 BROACH WAS USED AND SEATED APPROXIMATELY 5 MM DEEPER. AN ATTEMPT TO REDUCE THE HIP WITHOUT CALCAR REAMING RESULTED IN A MEDIAL CALCAR FRACTURE, WHICH WAS MANAGED WITH A CABLE. A SIZE 1 STANDARD QUADRA P CEMENTED STEM WAS IMPLANTED. THE SURGERY WAS COMPLETED WITHOUT FURTHER ISSUES. POST-OPERATIVE X-RAY SHOWS A SLIGHT INCREASE IN OFFSET AND A SLIGHT DECREASE IN LEG LENGTH.
Patient problems: Bone Fracture(s)
MAUDE report 23838612 ↗InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING BROACHING, A SMALL MEDIAL CALCAR FRACTURE OCCURRED, LIKELY DUE TO IMPINGEMENT BETWEEN THE AMIS BIKINI PINCER BROACH HANDLE AND THE PATIENT'S CALCAR BONE WHEN ATTEMPTING TO ADVANCE THE M-FINITY BROACH (PROBABLY SIZE 4) BEYOND THE OSTEOTOMY. THE MINOR FRACTURE REQUIRED NO INTERVENTION; THE SURGEON CALCAR REAMED THE FRACTURE AWAY ANDA COLLARED STEM WAS SUCCESSFULLY IMPLANTED. ACCORDING TO THE SURGICAL TECHNIQUE, THE BROACH SHOULD NOT BE INSERTED BEYOND THE FEMORAL OSTEOTOMY LEVEL.
Patient problems: Bone Fracture(s)
MAUDE report 23579844 ↗MalfunctionAug 12, 2025Fracture; Fracture
DURING HIP SURGERY, THE IMPACTOR TERMINAL BROKE INSIDE THE CUP DURING IMPACTION. THE BREAKAGE WAS NOT NOTICED AND THE SURGEON PROCEEDED WITH THE POSITIONING OF THE LINER BUT THE LINER COULD NOT BE COUPLED WITH THE CUP. WHILE TRYING TO SEATING THE LINER THE SURGEON NOTICED THE BROKEN IMPACTOR TERMINAL INSIDE THE CUP, REMOVED IT AND WAS ABLE TO PLACE THE LINER CORRECTLY. SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES OF DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22782906 ↗MalfunctionAug 6, 2025Fracture; Fracture
DURING REVISION OF M-VIZION STEM (B)(4), THE TIP OF THE LONG SCREWDRIVER 5MM BROKE INSIDE THE SCREW; IT COULD NOT BE RECOVERED AND WAS LEFT IN THE PATIENT. THE SCREW HAS BEEN REPORTED TO BE COMPLETELY TIGHTENED AND THE CONSTRUCT SEEMED STABLE. TORQUE LIMITER WAS USED AND WAS REPORTED TO HAVE REACHED THE TARGET TORQUE. THIS IS THE SAME PATIENT AND THE SAME TORQUE LIMITER INVOLVED IN (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22725447 ↗MalfunctionJul 18, 2025Fracture; Fracture
DURING FINAL TIGHTENING OF THE DEFINITIVE SCREW THE TIP OF THE SHORT SCREWDRIVER 5MM BROKE INSIDE THE SCREW; IT COULD NOT BE RECOVERED AND WAS LEFT IN THE PATIENT. THE SCREW HAS BEEN REPORTED TO BE COMPLETELY TIGHTENED AND THE CONSTRUCT SEEMED STABLE. TORQUE LIMITER WAS USED AND WAS REPORTED TO HAVE REACHED THE TARGET TORQUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22541065 ↗MalfunctionJun 5, 2025Material Twisted/Bent; Material Twisted/Bent
AFTER PROXIMAL BODY INSERTION, THE SURGEON WASN'T HAPPY WITH THE STEM VERSION AND WANTED TO CHANGE IT. THE PROXIMAL BODY HANDLE WAS SCREWED ON THE NECK AND THE SMALL ROD PLACED INSIDE WITH THE T-HANDLE. BUT IT WAS IMPOSSIBLE TO REMOVE THE PROXIMAL BODY BECAUSE THE HANDLE WAS STARTING TO BEND. THE SURGEON CHANGED THE CUP TO A DUAL MOBILITY TO COMPENSATE FOR THE VERSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22149349 ↗MalfunctionMar 28, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
M-VIZION STEM WAS IMPLANTED ON (B)(6) 2025. THE PATIENT NEEDED TO BE REVISED BECAUSE WAS EXPERIENCING PAIN, INSTABILITY AND LEG LENGTH DISCREPANCY, DUE TO A TOO SHORT PROXIMAL BODY IMPLANTED AT THE PRIMARY SURGERY. THE REVISION SURGERY TOOK PLACE 1 MONTH AFTER THE PRIMARY SURGERY AND THE PLAN WAS TO REVISE ONLY THE PROXIMAL BODY (MDR 2025-00242). HOWEVER, THE DISASSEMBLY ROD BENT DURING PROXIMAL STEM EXTRACTION FROM THE DISTAL BODY. DESPITE THE ATTEMPTS, THE PROXIMAL BODY COULD NOT BE REMOVED FROM THE DISTAL STEM, THEREFORE THE SURGEON DECIDED TO REMOVE THE ENTIRE STEM (PROXIMAL + DISTAL). SURGERY WAS EXTENDED BY ABOUT 15 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21717552 ↗MalfunctionJan 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE AMISTEM BROACH COULD NOT BE RE-ENGAGE TO THE BROACH HANDLE TO GET THE BROACH OUT FROM THE PATIENT. MULTIPLE ATTEMPTS FOR UP TO 30 MINUTES TO RE-ENGAGE IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21168799 ↗MalfunctionDec 30, 2024Break; Break
WHILE THE SURGEON WAS DRILLING TO INSERT THE SCREWS INTO THE CUP, THREE DIFFERENT BAYONET DRILL BITS BROKE. THE THIRD BROKEN DRILL GOT STUCK IN THE PATIENT (THE SMALLEST ONE). TO RETRIEVE IT, THE SURGEON HAD TO REMOVE THE CUP AND FELT MORE SECURE IN IMPLANTING A NEW ONE (SAME REF, DIFFERENT LOT). THE SCREWS WERE SUCCESSFULLY IMPLANTED WITH COMPETITOR DRILL BITS. 20-25 MIN DELAY REPORTED. PATIENT'S BONE QUALITY WAS HARD/SCLEROTIC. DRILL GUIDE WAS USED (CURVED DRILL GUIDE - GOLDEN TIP, REF 01.10.10.372).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21033592 ↗InjuryOct 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE TRIAL HEAD Ø 32 DISLOCATED DURING TRIAL REDUCTION WITH THE FINAL FEMORAL STEM AND WAS LOST IN THE PATIENT'S ABDOMEN. THE SURGEON FOR THE SPECIFIC REMOVAL WAS NOT AVAILABLE AND THE TRIAL HEAD WAS RECOVERED THE NEXT DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20449191 ↗MalfunctionOct 11, 2024Material Integrity Problem; Material Integrity Problem
DURING HIP PRIMARY SURGERY, THE SURGEON WANTED TO REMOVE THE STD SIZE 4 STEM AS IT WAS IMPLANTED A WRONG SIZE RESULTING IN A TOO HIGH IMPLANT AND IMPLANT A SIZE 3. HOWEVER, THE FIXATION WAS GOOD AND THE SURGEON COULD NOT GET THE STEM OUT, USING THE STEM REPOSITIONER AND SCREWED STEM EXTRACTOR. AFTER REPEATED ATTEMPTS, THE STEM REPOSITIONER HAD WORN OUT AND THE STEM WAS LEFT IN PLACE. THE DEVICE WAS NOT DAMAGED BEFORE USING IT. CUP SIZE S AND STD SIZE 4 STEM HAS BEEN IMPLANTED, WITH THE PLANNED OFFSET. ONE HOUR DELAY OCCURRED TO RELEASE ALL LIGAMENTS TO INCREASE THE LEG'S LEGHT (TOTAL TIME SUGERY 2HR AND 15MIN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20426603 ↗InjurySep 18, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
FIBULA FRACTURE DETECTED 5 DAYS AFTER AMIS SURGERY. NO ADDITIONAL SURGERY PLANNED. THE SURGEON REPORTS THAT THE FRACTURE HAPPENED WHILE THE PATIENT'S FOOT WAS IN THE AMIS SHOE.
Patient problems: Bone Fracture(s)
MAUDE report 20244206 ↗MalfunctionSep 6, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE TRIAL LINER MONOBLOC DMF-MMETAL RING CAME OFF DURING HIP TRAILING. THE TRIAL COULD STILL BE USED BUT WAS NOT EASILY IDENTIFIABLE DURING X-RAY FOR ORIENTATION. SURGERY COMPLETED SUCCESSFULLY.
Patient problems: Foreign Body In Patient
MAUDE report 20155191 ↗
Other Medacta International SA products
- GMK Sphere Total Knee System209 models · 2,306 reports
- GMK Primary Total Knee System99 models · 876 reports
- Shoulder System63 models · 716 reports
- AMIStem H Femoral Stems20 models · 679 reports
- Mpact Acetabular System68 models · 609 reports
- Mectacer Biolox Delta Femoral Ball Head15 models · 551 reports
- Quadra H femoral stems32 models · 354 reports
- MectaLIF Anterior6 models · 4 reports · 6 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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