Knee InstrumentsRecalls & reported problems across all models
Medacta International SA · 33 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 99
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 1
We found 33 models of Knee Instruments by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 99 adverse event reports in the FDA's MAUDE database, received between Jul 14, 2017 and Sep 11, 2026 — classified as 13 injuries, 86 malfunctions.
The most frequently reported specific device problem is “Fracture” (32 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
Knee Instruments recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 13, 2022Terminated
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
Z-1247-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported Knee Instruments problems
Device problems
- Fracture32
- Material Fragmentation31
- Break24
- Adverse Event Without Identified Device or Use Problem5
- Crack2
- Device Fell2
- Appropriate Device Problem Term/Code Not Available1
- Component Missing1
Patient problems
- No Known Impact Or Consequence To Patient39
- No Clinical Signs, Symptoms or Conditions24
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available9
- Bone Fracture(s)8
- Foreign Body In Patient6
- No Information6
- No Code Available3
- Device Embedded In Tissue or Plaque1
Knee Instruments models
33 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Knee Instruments 11.01041Orthopedic Manual Surgical Instrument1 recall0 reports
- Knee Instruments 11.00005Orthopedic Manual Surgical Instrument18 reports
- Knee Instruments 11.01002Orthopedic Manual Surgical Instrument16 reports
- Knee Instruments 02.07.10.8652Orthopedic Manual Surgical Instrument13 reports
- Knee Instruments 02.07.10.8651Orthopedic Manual Surgical Instrument9 reports
- Knee Instruments 11.01001Orthopedic Manual Surgical Instrument8 reports
- Knee Instruments 11.01025Orthopedic Manual Surgical Instrument3 reports
- Knee Instruments 02.07.10.2303Orthopedic Manual Surgical Instrument3 reports
- Knee Instruments 11.00009Orthopedic Manual Surgical Instrument2 reports
- Knee Instruments 11.00004Orthopedic Manual Surgical Instrument2 reports
- Knee Instruments 02.07.10.1040Orthopedic Manual Surgical Instrument2 reports
- Knee Instruments 02.12.10.0008Orthopedic Manual Surgical Instrument2 reports
- Knee Instruments 11.00008Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 11.01024Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 11.01032Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 11.01033Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 11.01035Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 11.01036Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 11.11024Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 02.07.10.4048Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 02.07.10.2294Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 02.07.10.2299Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 02.02.10.0001Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 02.12.10.0103Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 02.18.10.0031Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 02.09.10.0102Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 02.07.10.4741Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 02.07.10.4742Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 02.15.10.0001Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 02.12.10.1961Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 1.100Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 02.18.10.0170Orthopedic Manual Surgical Instrument1 report
- Knee Instruments 02.07.10.4888Orthopedic Manual Surgical Instrument1 report
Recent Knee Instruments adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Fracture
During a NextAR surgery, the 3.2 x 150 mm Meche-Triangle pin broke while the surgeon was repositioning it. The broken fragment could not be retrieved and was therefore left in situ. A back-up pin was subsequently used to complete the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732102 ↗MalfunctionAug 27, 2026No Apparent Adverse Event
The trial insert 10mm did not engage the trial tibial baseplate since the anterior clipping part of the trial insert was broken. The cause and the timing of the breakage was unknown. The surgery was completed successfully, but the insert thickness was selected without an adequate trial reduction. The surgery time was 3 hours, and the delay time was 30 minutes.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50474948 ↗MalfunctionMar 31, 2026Fracture
THE ANTIROTATIONAL INSERT OF THE TRIAL OFFSET 3MM BROKE AND REMAINED ATTACHED THE TIBIAL PUNCHER, WHILE THE BODY OF THE TRIAL OFFSET REMAINED STUCK IN THE TIBIAL CANAL. ABOUT 45 MINUTES WERE REQUIRED TO REMOVE THE BROKEN PART AND THE SURGEON HAD TO REMOVE PART OF THE TIBIAL BONE TO BE ABLE TO GRAB THE OFFSET. BROKEN PART RETRIEVED AND SURGERY COMPLETED SUCCESSFULLY. BONE QUALITY NORMAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24738824 ↗MalfunctionJan 29, 2026Fracture
THE ANTI-ROTATIONAL INSERT OF THE TRIAL OFFSET 3MM BROKE DURING THE REMOVAL OF THE TRIAL ASSEMBLY. CLAMP USED TO REMOVE THE PART (5 MINUTES DELAY TO RECOVER THE PIECE). SURGERY COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24208585 ↗MalfunctionJan 13, 2026Adverse Event Without Identified Device or Use Problem
DURING REMOVAL, THE PIN FRACTURED, LEAVING THE THREADED PORTION RETAINED IN THE PATIENT. THE SURGEON ASSESSED A RISK OF FRACTURE AND DECIDED TO LEAVE THE FRAGMENT IN SITU. 30 MINUTES OF DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24051154 ↗MalfunctionJan 8, 2026Fracture
AT 6 WEEKS POST-OP X-RAYS SHOWED AN ARTIFACT IN THE POSTERIOR PART OF THE FEMUR. BASED ON THE IMAGES IT IS HYPOTHESIZED TO BE THE TIP OF THE CENTRAL BODY OF THE EFFICIENCY IMPACTOR/EXTRACTOR, BUT THIS CANNOT BE CONFIRMED. SURGICAL STAFF REPORTED THAT NO BREAKAGE WAS NOTICED DURING PRIMARY SURGERY. ACCORDING TO THE SURGEON THE PATIENT PRESENTS A NORMAL LEVEL OF PAIN, COMPATIBLE WITH 6 WEEKS FOLLOW-UP, AND NO REVISION IS CURRENTLY SCHEDULED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24003049 ↗MalfunctionJul 17, 2025Fracture; Fracture
DURING THE PRIMARY KNEE SURGERY AND WHILE THE SURGEON WAS DISENGAGING THE TIBIAL FIN PUNCH, THE 5MM TRIAL OFFSET WITH LOCKING SYSTEM BROKE. ALL BROKEN FRAGMENTS WERE RECOVERED AND THERE WAS NO DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22529148 ↗MalfunctionJul 16, 2025Material Fragmentation; Material Split, Cut or Torn
METAL FRAGMENT NOTICED ON POSTOP XRAYS ENCAPSULATED IN BONE CEMENT IN TIBIA CANAL. WHILE LOOKING THROUGH SURGICAL INSTRUMENTS, FOUND METAL SHEARED OFF TIBIA REAMING GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22518816 ↗MalfunctionJul 4, 2025Fracture; Fracture
THE ANTIROTATIONAL INSERT OF THE TRIAL OFFSET 3MM BROKE. BROKEN PART RETRIEVED AND SURGERY COMPLETED SUCCESSFULLY. 1 HOUR DELAY OCCURRED TO REMOVE THE BROKEN PART. THE SURGEON HAD TO CUT THE DIAPHYSIS TO BE ABLE TO GRAB THE OFFSET AND PULL OUT THE OFFSET AND STEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22403097 ↗MalfunctionJun 19, 2025Break; Break
THE SURGEON FOUND THAT THE TIP OF DRILL PIN WAS FRACTURED AFTER REMOVING THE PIN FROM MYKNEE FEMORAL CUTTING BLOCK. THE SURGEON CONFIRMED FROM THE FLUOROSCOPY IMAGES THAT THE BROKEN PIN TIP REMAINED INSIDE THE BONE. A SMALL OPENING WAS MADE IN THE FEMUR, AND THE PIN FRAGMENT WAS REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY. TOTAL SURGERY TIME WAS 2.5 HOURS, THE DELAY TIME WAS 30-40 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22289252 ↗InjuryApr 25, 2025Fracture; Fracture
BROKEN PIN DETECTED IN THE X-RAY POST OPERATION. IT WAS USED FOR FIXATION OF THE NEXTAR CAMERA TO THE CORACOID. THE PATIENT WAS TAKEN BACK TO SURGERY THE DAY AFTER THE PRIMARY TO REMOVE THE PIN.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 21908715 ↗MalfunctionApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PIN BROKE WHILE TAKING IT OUT FROM THE 2-IN-1 CUTTING GUIDE. THE BROKEN PART REMAINED STUCK IN THE BONE. BONE QUALITY WAS VERY GOOD. WHEN THE SURGERY WAS COMPLETED, THE PATIENT WAS TURNED INTO A PRONE POSITION TO REMOVE THE PIN PART FROM POSTERIOR APPROACH. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, BUT THE SURGERY WAS PROLONGED BY ABOUT 40 MINUTES, AND THE TOTAL SURGERY TIME WAS APPROXIMATELY 2 HOURS. THE SURGEON REPORTED THAT IT IS POSSIBLE THE PIN WAS ALREADY WORN BEFORE USE, SINCE THE SET HAS BEEN WITH THE HOSPITAL FOR QUITE SOME TIME. A FURTHER INDICATION OF THE PRIOR WEAR MIGHT BE THAT THERE WAS NO LOT NUMBER READABLE ON THE PINS ANYMORE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21890741 ↗MalfunctionMar 19, 2025Fracture; Fracture
DURING THE COMPETITOR REVISION KNEE SURGERY, THE 5MM TRIAL OFFSET THREADED PIECE BROKE OUT OF CHASSIS. THE KEEL CAME OUT WITH THREADS ENGAGED INTO SMALL PIECE THAT CAME OUT OF OFFSET TRIAL, AND THE OFFSET TRIAL AND STEM WERE THEN STUCK IN TIBIAL CANAL. THE REP TRIED FOR 15-20 MIN TO FIND INSTRUMENTATION TO GRAB ONTO OFFSET TRIAL AND REMOVE FROM CANAL. THERE WAS A 20-MINUTE DELAY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21642256 ↗InjuryMar 14, 2025Fracture; Fracture
DURING MOTO PFJ SURGERY, THE SPIKE ROD AND THE ANTERIOR GUIDE COULD NOT BE COUPLED WITH EACH OTHER. THE RETAINER FOR THE SPIKE SCREW ON THE GUIDE WAS DETACHED, THE SPIKE SCREW BACKED OUT AND FELL INTO THE PATIENT. THE SCREW WAS NOTICED ONLY WITH POST-OPERATIVE X-RAY. THE SURGEON DECIDED TO REOPERATE THE PATIENT TO REMOVE THE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21604380 ↗MalfunctionFeb 20, 2025Fracture; Fracture
THE ANTIROTATIONAL INSERT OF THE TRIAL OFFSET 3MM BROKE AND REMAINED INSIDE THE TRIAL FEMUR AND STEM. THE OPERATION WAS EXTENDED BY AROUND 30 MINUTES AND THE PATIENT HAD TO REMAIN UNDER ANESTHESIA LONGER. IN ADDITION, BONE HAD TO BE REMOVED FROM THE ANTERIOR FEMORAL BONE ABOVE THE OFFSET CONNECTOR IN ORDER TO BE ABLE TO GRASP THE SHAFT WITH FORCEPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21420549 ↗
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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