GMK Sphere Total Knee SystemRecalls & reported problems across all models
Medacta International SA · 209 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,306
- Deaths reported
- 0
- Injuries reported
- 2,265
- Recalls
- 0
We found 209 models of GMK Sphere Total Knee System by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 2,306 adverse event reports in the FDA's MAUDE database, received between Jun 27, 2017 and Aug 13, 2026 — classified as 2,265 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (527 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 GMK Sphere Total Knee System problems
Device problems
- Adverse Event Without Identified Device or Use Problem685
- Appropriate Device Problem Term/Code Not Available529
- Device Appears to Trigger Rejection527
- Unstable154
- Loosening of Implant Not Related to Bone-Ingrowth125
- Loose or Intermittent Connection84
- Device Dislodged or Dislocated61
- Insufficient Device Problem Information39
Patient problems
- Unspecified Infection659
- Joint Laxity568
- Medical device site infection353
- Pain179
- Joint Disorder164
- Loss of Range of Motion86
- Implant Pain75
- Insufficient Information48
GMK Sphere Total Knee System models
209 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- GMK Sphere Total Knee System 02.12.0510FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer99 reports
- GMK Sphere Total Knee System 02.12.0410FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer90 reports
- GMK Sphere Total Knee System 02.12.0410FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer87 reports
- GMK Sphere Total Knee System 02.12.0510FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer68 reports
- GMK Sphere Total Knee System 02.12.0310FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer66 reports
- GMK Sphere Total Knee System 02.12.0310FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer60 reports
- GMK Sphere Total Knee System 02.12.E0410FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer56 reports
- GMK Sphere Total Knee System 02.12.E0510FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer43 reports
- GMK Sphere Total Knee System 02.12.0210FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer41 reports
- GMK Sphere Total Knee System 02.12.E0410FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer39 reports
- GMK Sphere Total Knee System 02.12.0512FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer38 reports
- GMK Sphere Total Knee System 02.12.0412FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer33 reports
- GMK Sphere Total Knee System 02.12.0511FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer33 reports
- GMK Sphere Total Knee System 02.12.0210FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer32 reports
- GMK Sphere Total Knee System 02.12.0512FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer32 reports
- GMK Sphere Total Knee System 02.12.0004RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer30 reports
- GMK Sphere Total Knee System 02.12.0312FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer29 reports
- GMK Sphere Total Knee System 02.12.0412FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer29 reports
- GMK Sphere Total Knee System 02.12.0311FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer29 reports
- GMK Sphere Total Knee System 02.12.0411FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer29 reports
- GMK Sphere Total Knee System 02.12.T3I4LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer28 reports
- GMK Sphere Total Knee System 02.12.E0510FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer27 reports
- GMK Sphere Total Knee System 02.12.0004LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer26 reports
- GMK Sphere Total Knee System 02.12.T3I4RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer25 reports
- GMK Sphere Total Knee System 02.12.0005RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer24 reports
- GMK Sphere Total Knee System 02.12.0411FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer24 reports
- GMK Sphere Total Knee System 02.12.0312FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer23 reports
- GMK Sphere Total Knee System 02.12.0023RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer23 reports
- GMK Sphere Total Knee System 02.12.0003LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer22 reports
- GMK Sphere Total Knee System 02.12.0003RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer22 reports
- GMK Sphere Total Knee System 02.12.0211FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer22 reports
- GMK Sphere Total Knee System 02.12.0511FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer22 reports
- GMK Sphere Total Knee System 02.12.E0210FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer22 reports
- GMK Sphere Total Knee System 02.12.0024LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer21 reports
- GMK Sphere Total Knee System 02.12.0414FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer20 reports
- GMK Sphere Total Knee System 02.12.0610FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer20 reports
- GMK Sphere Total Knee System 02.12.0311FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer20 reports
- GMK Sphere Total Knee System 02.12.E0411FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer20 reports
- GMK Sphere Total Knee System 02.12.0211FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer19 reports
- GMK Sphere Total Knee System 02.12.E0310FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer19 reports
- GMK Sphere Total Knee System 02.12.E0411FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer19 reports
- GMK Sphere Total Knee System 02.12.E0511FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer19 reports
- GMK Sphere Total Knee System 02.12.0005LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer17 reports
- GMK Sphere Total Knee System 02.12.0514FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer17 reports
- GMK Sphere Total Knee System 02.12.0023LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer17 reports
- GMK Sphere Total Knee System 02.12.0022LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer17 reports
- GMK Sphere Total Knee System 02.12.E0310FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer17 reports
- GMK Sphere Total Knee System 02.12.0025LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer16 reports
- GMK Sphere Total Knee System 02.12.0413FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer16 reports
- GMK Sphere Total Knee System 02.12.E0412FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer16 reports
- GMK Sphere Total Knee System 02.12.0024RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer15 reports
- GMK Sphere Total Knee System 02.12.0025RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer14 reports
- GMK Sphere Total Knee System 02.12.0513FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer14 reports
- GMK Sphere Total Knee System 02.12.E0211FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer14 reports
- GMK Sphere Total Knee System 02.12.E0311FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer13 reports
- GMK Sphere Total Knee System 02.12.0002RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer12 reports
- GMK Sphere Total Knee System 02.12.0006LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer12 reports
- GMK Sphere Total Knee System 02.12.0212FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer12 reports
- GMK Sphere Total Knee System 02.12.0414FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer12 reports
- GMK Sphere Total Knee System 02.12.0022RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer12 reports
- GMK Sphere Total Knee System 02.12.0413FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer12 reports
- GMK Sphere Total Knee System 02.12.0513FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer12 reports
- GMK Sphere Total Knee System 02.12.E0210FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer12 reports
- GMK Sphere Total Knee System 02.12.0212FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer11 reports
- GMK Sphere Total Knee System 02.12.0514FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer11 reports
- GMK Sphere Total Knee System 02.12.0610FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer11 reports
- GMK Sphere Total Knee System 02.12.E0311FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer11 reports
- GMK Sphere Total Knee System 02.12.E0414FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer11 reports
- GMK Sphere Total Knee System 02.12.E0512FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer11 reports
- GMK Sphere Total Knee System 02.12.0214FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer10 reports
- GMK Sphere Total Knee System 02.12.T4I3RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer10 reports
- GMK Sphere Total Knee System 02.12.0313FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer10 reports
- GMK Sphere Total Knee System 02.12.E0413FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer10 reports
- GMK Sphere Total Knee System 02.12.E0512FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer10 reports
- GMK Sphere Total Knee System 02.12.0002LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer9 reports
- GMK Sphere Total Knee System 02.12.0314FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer9 reports
- GMK Sphere Total Knee System 02.12.0612FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer9 reports
- GMK Sphere Total Knee System 02.12.E0312FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer9 reports
- GMK Sphere Total Knee System 02.12.E0413FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer9 reports
- GMK Sphere Total Knee System 02.12.E0511FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer9 reports
- GMK Sphere Total Knee System 02.12.0006RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer8 reports
- GMK Sphere Total Knee System 02.12.0026RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer8 reports
- GMK Sphere Total Knee System 02.12.0611FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer8 reports
- GMK Sphere Total Knee System 02.12.0310CRRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer8 reports
- GMK Sphere Total Knee System 02.12.0007LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer7 reports
- GMK Sphere Total Knee System 02.12.0214FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer7 reports
- GMK Sphere Total Knee System 02.12.0417FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer7 reports
- GMK Sphere Total Knee System 02.12.0510CRRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer7 reports
- GMK Sphere Total Knee System 02.12.E0312FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer7 reports
- GMK Sphere Total Knee System 02.12.E0412FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer7 reports
- GMK Sphere Total Knee System 02.12.E0514FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer7 reports
- GMK Sphere Total Knee System 02.12.0517FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Sphere Total Knee System 02.12.0213FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Sphere Total Knee System 02.12.0313FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Sphere Total Knee System 02.12.0410CRRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Sphere Total Knee System 02.12.E0212FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Sphere Total Knee System 02.12.E0212FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Sphere Total Knee System 02.12.E0314FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Sphere Total Knee System 02.12.E0314FRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Sphere Total Knee System 02.12.E0514FLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
Recent GMK Sphere Total Knee System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Device Appears to Trigger Rejection
Revision surgery after 7 months from primary due to infection. The surgeon revised the liner to the same size.
Patient problems: Medical device site infection
MAUDE report 50232826 ↗InjuryAug 13, 2026Device Appears to Trigger Rejection
At about 5 months from the primary, the patient came in due to signs of infection and the pathogen is unknown. The surgeon performed a washout and revised the Flex 4R - 12mm insert to a same size insert. The surgery was completed successfully.
Patient problems: Medical device site infection
MAUDE report 50232824 ↗InjuryAug 11, 2026Device Appears to Trigger Rejection
At about 11 month from the primary, the patient came in due to signs of infection and the pathogen is unknown. The surgeon performed a washout and revised the Flex4L - 10mm insert to a same size insert. The surgery was completed successfully.
Patient problems: Medical device site infection
MAUDE report 50209597 ↗InjuryAug 11, 2026Device Appears to Trigger Rejection
At about 2 months after the primary, the patient in due to signs of an infection and the pathogen is unknown. The surgeon performed a washout and revised the liner. The surgery was completed successfully.
Patient problems: Medical device site infection
MAUDE report 50209581 ↗InjuryAug 11, 2026Device Appears to Trigger Rejection
At about 2 months from the primary, the patient came in due to signs of infection and the pathogen is unknown. The surgeon performed a washout and revised the Flex 5L - 11mm insert to a same size insert. The surgery was completed successfully.
Patient problems: Medical device site infection
MAUDE report 50209579 ↗InjuryAug 3, 2026Device Appears to Trigger Rejection
Revision surgery after 1 year and 2 months from the primary due to infection.The surgeon performed a washout and revised the poly. The surgery was completed successfully.
Patient problems: Medical device site infection
MAUDE report 50114137 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
At about 1 year and 4 months fro the primary, the patient came in reporting instability due to laxity and the cause of the laxity is unknown. The surgeon revised the GMK-SPHERE Tibial Insert from 10 mm to 13 mm to give the patient more stability. The surgery was completed successfully.
Patient problems: Joint Laxity
MAUDE report 50114136 ↗InjuryAug 3, 2026Device Appears to Trigger Rejection
The patient had a primary knee surgery on (b)(6) 2019. On (b)(6) 2025, the patient had instability and a & quot; clicking & quot; noise in knee and the cause is unknown. There was no reports of trauma. The surgeon revised the Flex S3L - 10mm insert to a Flex 3L - 14mm insert. The surgery was completed successfully "[MDR 2026-00469]". On (b)(6) 2026, the patient had signs of an infection and the cause is unknown. The surgeon performed a washout and revised the GMK-SPHERE tibial insert E-Cross - Flex 3L - 14mm with a new GMK-SPHERE tibial insert E-Cross - Flex 3L - 14mm. The surgery was completed successfully.
Patient problems: Medical device site infection
MAUDE report 50114127 ↗InjuryAug 3, 2026Device Appears to Trigger Rejection
At 6 weeks from primary, the patient came in due to signs of an infection and the pathogen is unknown. The surgeon performed a washout and revised the liner to a liner of the same size. The surgery was completed successfully.
Patient problems: Medical device site infection
MAUDE report 50114123 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
At about 1 year 11 months after the primary, the patient came in presenting knee instability. The surgeon revised the insert 11mm to 14mm insert for stability. The surgery was completed successfully. Several months prior to this revision, the patient fractured her ankle and dislocated her patella.
Patient problems: Joint Laxity
MAUDE report 50005868 ↗InjuryJul 22, 2026Device Appears to Trigger Rejection
REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 MONTH FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FLEX 5R - 10MM INSERT TO A SAME SIZE INSERT.
Patient problems: Medical device site infection
MAUDE report 25904705 ↗InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT'S NATURAL PATELLA AND REVISED THE INSERT FROM A 12MM INSERT TO A 13MM AT HIS DISCRETION.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 25854831 ↗InjuryJul 17, 2026Device Dislodged or Dislocated
PRIMARY SURGERY PERFORMED ON THE (B)(6) 2024. FIRST REVISION SURGERY PERFORMED ON THE (B)(6) 2026 DUE TO KNEE LAXITY. SECOND REVISION SURGERY PERFORMED ON THE (B)(6) 2026 DUE TO DISENGAGEMENT OF THE LINER FROM THE TIBIAL TRAY. EXPLANTATION OF THE LINER AND IMPLANTATION OF A TIBIAL INSERT FIXED SPHERE FLEX USING THE DEDICATED TORQUE LIMITER.
Patient problems: Joint Dislocation
MAUDE report 25854819 ↗InjuryJul 16, 2026Device Appears to Trigger Rejection
THE PATIENT HAD KNEE INSTABILITY DUE TO AN ATTENUATED PCL AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA OR A FALL. AT ABOUT 2 YEARS AND 2 MONTHS POST PRIMARY THE SURGEON REVISED THE FLEX 4R - 11MM INSERT TO A FLEX 4R - 13MM FOR INCREASED STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25838717 ↗InjuryJul 16, 2026Adverse Event Without Identified Device or Use Problem
AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY MID-FLEXION DUE TO A PCL TEAR AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT FROM 11MM TO 17MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Laxity
MAUDE report 25838714 ↗
Other Medacta International SA products
- 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
- GMK Revision Total Knee System71 models · 304 reports
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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