TOUCH® CMC 1 CTO109Recalls & reported problems
Keri Medical SA · Class 3 · Implant
All models of TOUCH CMC 1 (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07640181160099), received between Nov 7, 2025 and Sep 18, 2026 — classified as 14 injuries.
The most frequently reported specific device problem is “Migration” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Migration6
- Device Dislodged or Dislocated3
- Osseointegration Problem3
- Loosening of Implant Not Related to Bone-Ingrowth2
- Microbial Contamination of Device2
- Naturally Worn2
- Adverse Event Without Identified Device or Use Problem1
- Biocompatibility1
Patient problems
- Aseptic loosening3
- Bone Fracture(s)3
- Implant Pain3
- Inadequate Osseointegration3
- Failure of Implant2
- Skin Infection2
- Wound Infection2
- Extraskeletal ossification1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Migration
Patient problems: Inadequate Osseointegration
MAUDE report 50821128 ↗InjuryAug 10, 2026Device Appears to Trigger Rejection
It was reported that the patient underwent a revision due to infection. The patient presented redness of skin, pain and swelling approximately two week post implantation.
Patient problems: Failure of Implant
MAUDE report 50195147 ↗InjuryMay 26, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL JOINT ARTHROPLASTY WITH A TOUCH CMC1 PROSTHESIS APPROXIMATELY 2 YEARS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2026, FOLLOWING DETECTION OF ASEPTIC CUP LOOSENING. THE SURGEON REPORTED THAT HE BELIEVED THE CUP NEVER OSSEOINTEGRATED IN THE TRAPEZIUM. DURING THE REVISION SURGERY, THE CUP AND NECK COMPONENTS WERE REMOVED, AND THE SURGEON PROCEEDED WITH A TRAPEZIECTOMY.
Patient problems: Aseptic loosening
MAUDE report 25277499 ↗InjuryMay 7, 2026Device Dislodged or Dislocated; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL JOINT ARTHROPLASTY OF TOUCH CMC1 PROSTHESIS ON (B)(6) 2026. INTRAOPERATIVELY SHE SHOWED SIGNS OF SOFT BONE, THE CUP AFTER IMPACTION IMMEDIATELY SUBSIDED AND ROTATED ULNAR; IT REMAINED STABLE THROUGH RANGE OF MOTION AND DID NOT DISLOCATE. SUBSEQUENTLY, DURING THE 6 WEEK FOLLOW-UP IT WAS DISCOVERED THE TRAPEZIUM HAS FRACTURED CAUSING THE IMPLANT TO FAIL; THE RADIAL SIDE OF THE TRAPEZIUM FRACTURED AND THE CUP HAS DISLODGED. REPORTED PATIENT LIMITED FUNCTION, NO TRAUMA WAS REPORTED THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2026, THE NECK AND CUP WERE EXPLANTED AND THE SURGEON PERFORMED A SUSPENSIONPLASTY.
Patient problems: Bone Fracture(s); Inadequate Osseointegration
MAUDE report 25112099 ↗InjuryMay 4, 2026Implant subsidence
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL JOINT ARTHROPLASTY OF TOUCH CMC1 PROSTHESIS ON (B)(6) 2026. INTRAOPERATIVELY SHE SHOWED SIGNS OF SOFT BONE, THE CUP AFTER IMPACTION IMMEDIATELY SUBSIDED AND ROTATED ULNAR. SUBSEQUENTLY, DURING THE 6-WK FOLLOW-UP IT WAS DISCOVERED THE TRAPEZIUM HAS FRACTURED CAUSING THE IMPLANT TO FAIL; THE RADIAL SIDE OF THE TRAPEZIUM FRACTURED, AND THE CUP HAS DISLODGED. REPORTED PATIENT LIMITED FUNCTION, NO TRAUMA WAS REPORTED. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2026, THE NECK AND CUP WERE EXPLANTED, AND THE SURGEON PERFORMED A SUSPENSIONPLASTY.
Patient problems: Failure of Implant
MAUDE report 25073388 ↗InjuryApr 9, 2026Microbial Contamination of Device
IT WAS REPORTED THAT AFTER FOLLOWING SURGICAL POST OP INSTRUCTIONS, THE SURGICAL DRESSINGS HAVE BEEN REMOVED. THE PATIENT NOTED UNUSUAL COLORING OF THE SURGICAL SITE AND RETURNED TO THE HOSPITAL FOR THE WOUND TO BE CHECKED. FOLLOWING AN X-RAY OF THE HAND, THE SURGICAL TEAM IDENTIFIED ABNORMAL TISSUE GROWTH AROUND THE IMPLANTS. THE PATIENT WAS BROUGHT BACK TO THE HOSPITAL FOR A SECONDARY PROCEDURE WHERE THE IMPLANTS WERE REMOVED AND THE SURGICAL SITE WAS CLEANED. THE IMPLANTS APPEARED TO HAVE BEEN INFECTED IN THE PATIENT. IMPLANTS HAD TO BE REMOVED. SWAB SAMPLES WERE TAKEN FROM EACH COMPONENT OF THE PROSTHESIS AND THE SURROUNDING TISSUES. THE REMOVED PROSTHESIS HAS BEEN SENT FOR DECONTAMINATION AND WILL BE RETURNED TO THE OFFICE.
Patient problems: Skin Infection; Wound Infection
MAUDE report 24831439 ↗InjuryApr 8, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT UNDERWENT TOTAL JOINT ARTHROPLASTY OF TOUCH CMC1 PROSTHESIS ON (B)(6) 2024. THE PATIENT REMAINED ASYMPTOMATIC UNTIL (B)(6) 2025, WHEN HE EXPERIENCED A SUDDEN ONSET OF PAIN WHILE LIFTING HIS NIECE. THE PATIENT WAS RE-EVALUATED IN (B)(6) 2026, AT WHICH TIME IMAGING SHOWED A CHANGE IN CUP ALIGNMENT WITHOUT CLEAR SIGNS OF INSTABILITY OR OSTEOLYSIS; THE CUP WAS THEREFORE SUSPECTED TO BE LOOSE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6), 2026, DURING THE SURGERY IT WAS ASSESSED THAT DUE TO INSUFFICIENT BONE STOCK TO ACHIEVE STABLE FIXATION OF A 10 MM CUP COMPONENT, THE PROCEDURE WAS CONVERTED TO A TRAPEZIECTOMY.
Patient problems: Aseptic loosening; Implant Pain
MAUDE report 24815704 ↗InjuryApr 1, 2026Device Dislodged or Dislocated; Naturally Worn; Osseointegration Problem
THE SURGEON REPORTED THAT A 70-YEAR-OLD PATIENT UNDERWENT REVISION SURGERY 28 MONTHS AFTER THE INITIAL OPERATION DUE TO PAIN ON EXERTION, DESCRIBED AS SIMILAR TO THE SYMPTOMS EXPERIENCED PRIOR TO IMPLANTATION OF THE PROSTHESIS. THIS SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2026, CONSISTING OF RELEASE OF THE PERI-PROSTHETIC TISSUES AND MAXIMAL REMOVAL OF THE OSSIFICATION. IT WAS NOT POSSIBLE TO ADVANCE THE STEM ANY FURTHER. THE CUP WAS THEREFORE REMOVED AND REIMPLANTED DEEPER AND THE NECK WAS REPLACED.
Patient problems: Extraskeletal ossification; Implant Pain
MAUDE report 24760627 ↗InjuryMar 17, 2026Device Dislodged or Dislocated; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT TOTAL JOINT ARTHROPLASTY OF TOUCH CMC1 ON (B)(6) 2025. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION ON (B)(6) 2026 DUE TO CUP MALPOSITIONING. THE SURGEON REPLACED THE DEVICE WITH A 9MM CONICAL CUP, AND A NEW HOLE WAS EXCAVATED BESIDE THE ORIGINAL ONE, BORDERED BY A CIRCULAR ARRANGEMENT OF BONES.
Patient problems: Aseptic loosening
MAUDE report 24616280 ↗InjuryMar 13, 2026Break; Naturally Worn; Migration
IT WAS REPORTED THAT PATIENT UNDERWENT A JOINT ARTHROPLASTY OF TOUCH CMC1 PROSTHESIS REVISION ON (B)(6) 2025. SUBSEQUENTLY, THE PATIENT UNDERWENT A SECOND REVISION DUE TO BREAKAGE OF THE POLYETHYLENE (PE) LINER. THE SURGEON REVISED THE NECK AND THE CUP.
Patient problems: Joint Impingement
MAUDE report 24597892 ↗InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 75-YEAR-OLD FEMALE PATIENT FELL AND FRACTURED THE TRAPEZIUM ONE WEEK AFTER THE SURGERY. THE CUP WAS DETACHED. THE CUP AND NECK WERE REMOVED. IT WAS IMPOSSIBLE TO PUT ANOTHER CUP IN THE TRAPEZIUM. THIS LED TO A TRAPEZIECTOMY.
Patient problems: Bone Fracture(s)
MAUDE report 23875569 ↗InjuryNov 11, 2025Biocompatibility; Osseointegration Problem; Migration; Biocompatibility; Osseointegration Problem; Migration
THE PATIENT, A 62-YEAR-OLD MALE WITH A MANUAL/PHYSICAL OCCUPATION, REPORTED THE ONSET OF PAIN IN JULY WITHOUT ANY IDENTIFIED TRIGGERING FACTOR, DESPITE DOING WELL BETWEEN MARCH AND MAY 2025. IMMOBILIZATION WAS MAINTAINED FOR 7 DAYS. HE UNDERWENT A REVISION SURGERY ON (B)(6) 2025 LEADING TO TRAPEZIECTOMY.
Patient problems: Hypersensitivity/Allergic reaction; Implant Pain; Inadequate Osseointegration
MAUDE report 23520961 ↗InjuryNov 11, 2025Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT AFTER FOLLOWING SURGICAL POST OP INSTRUCTIONS, THE SURGICAL DRESSINGS HAVE BEEN REMOVED. THE PATIENT NOTED UNUSUAL COLORING OF THE SURGICAL SITE AND RETURNED TO THE HOSPITAL FOR THE WOUND TO BE CHECKED. FOLLOWING AN X-RAY OF THE HAND, THE SURGICAL TEAM IDENTIFIED ABNORMAL TISSUE GROWTH AROUND THE IMPLANTS. THE PATIENT WAS BROUGHT BACK TO THE HOSPITAL FOR A SECONDARY PROCEDURE WHERE THE IMPLANTS WERE REMOVED AND THE SURGICAL SITE WAS CLEANED. THE IMPLANTS APPEARED TO HAVE BEEN INFECTED IN THE PATIENT. IMPLANTS HAD TO BE REMOVED. SWAB SAMPLES WERE TAKEN FROM EACH COMPONENT OF THE PROSTHESIS AND THE SURROUNDING TISSUES. THE REMOVED PROSTHESIS HAS BEEN SENT FOR DECONTAMINATION AND WILL BE RETURNED TO THE OFFICE.
Patient problems: Skin Infection; Wound Infection
MAUDE report 23520599 ↗InjuryNov 7, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration
THE PATIENT IS A 60-YEAR-OLD ACTIVE MALE (DOB: (B)(6) 1965, WEIGHT UNKNOWN) WHO UNDERWENT SURGERY ON (B)(6) 2025, DURING WHICH BONE GRAFTS WERE REQUIRED TO PLACE THE CUP DUE TO A CYST; POSTOPERATIVE IMMOBILISATION WAS PLANNED FOR 4 WEEKS BUT WAS DISCONTINUED BY MISTAKE AFTER 7 DAYS. AT A STANDARD POSTOPERATIVE CONTROL VISIT, THE PATIENT REPORTED NO PAIN OR DYSFUNCTION BUT X-RAYS SHOWED CUP MIGRATION AND TRAPEZIUM FRACTURE. ON (B)(6) 2025, A REVISION SURGERY WAS PERFORMED WITH THE SALES REPRESENTATIVE PRESENT; NO METALLOSIS WAS OBSERVED, THE CUP HAD MIGRATED FROM THE TRAPEZIUM INTO THE SURROUNDING TISSUE, AND THE TRAPEZIUM WAS FRACTURED IN THE MIDDLE, PREVENTING PLACEMENT OF A NEW CUP.
Patient problems: Bone Fracture(s)
MAUDE report 23497041 ↗
Other Prosthesis, Finger, Semi-Constrained, Metal/Polymer devices
- TOUCH® CMC 1 NTO156Keri Medical SA · Prosthesis, Finger, Semi-Constrained, Metal/Polymer18 reports
- TOUCH® CMC 1 NTO158Keri Medical SA · Prosthesis, Finger, Semi-Constrained, Metal/Polymer18 reports
- TOUCH® CMC 1 NTO08Keri Medical SA · Prosthesis, Finger, Semi-Constrained, Metal/Polymer11 reports
- TOUCH® CMC 1 CTO09Keri Medical SA · Prosthesis, Finger, Semi-Constrained, Metal/Polymer9 reports
- TOUCH® CMC 1 NTO1510Keri Medical SA · Prosthesis, Finger, Semi-Constrained, Metal/Polymer6 reports
- TOUCH® CMC 1 NTO06Keri Medical SA · Prosthesis, Finger, Semi-Constrained, Metal/Polymer5 reports
- TOUCH® CMC 1 NTO010Keri Medical SA · Prosthesis, Finger, Semi-Constrained, Metal/Polymer4 reports
- Stem holder 112-A32000Keri Medical SA · Prosthesis, Finger, Semi-Constrained, Metal/Polymer1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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