SPECIALISTRecalls & reported problems across all models
Depuy Orthopaedics, Inc. · 12 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 110
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 12 models of SPECIALIST by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 110 adverse event reports in the FDA's MAUDE database, received between Aug 3, 2017 and Apr 3, 2026 — classified as 1 injury, 109 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (58 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 SPECIALIST problems
Device problems
- Device-Device Incompatibility58
- Break27
- Component Missing16
- Detachment of Device or Device Component9
- Appropriate Device Problem Term/Code Not Available4
- No Apparent Adverse Event3
- Structural Problem3
- Mechanical Problem2
Patient problems
- No Consequences Or Impact To Patient54
- No Clinical Signs, Symptoms or Conditions44
- No Information5
- Insufficient Information4
- No Code Available4
- Not Applicable2
- Unspecified Infection1
SPECIALIST models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SPECIALIST 96-6670CLAMP92 reports
- SPECIALIST 97-6750INSTRUMENT, CUTTING, ORTHOPEDIC3 reports
- SPECIALIST 86-5049CLAMP2 reports
- SPECIALIST 96-6350TEMPLATE2 reports
- SPECIALIST 97-6746INSTRUMENT, CUTTING, ORTHOPEDIC2 reports
- SPECIALIST 97-6747INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2 reports
- SPECIALIST 97-6749INSTRUMENT, CUTTING, ORTHOPEDIC2 reports
- SPECIALIST 96-6274TEMPLATE1 report
- SPECIALIST 96-6707TEMPLATE1 report
- SPECIALIST 96-6708TEMPLATE1 report
- SPECIALIST 97-6751INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- SPECIALIST 97-6755GAUGE, DEPTH1 report
Recent SPECIALIST adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2026Device-Device Incompatibility
IT WAS REPORTED THAT FEMORAL IMPACTOR HAD A CRACK IN IT AND PATELLA CLAMP WOULDN¿T HOLD THE ATTACHMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24775712 ↗MalfunctionApr 1, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE PATELLA CLAMPS WOULD NOT HOLD ATTACHMENTS. THE SPACER BLOCKS HAD CRACKS IN THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24752742 ↗MalfunctionApr 1, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE PATELLA CLAMPS WOULD NOT HOLD ATTACHMENTS. THE SPACER BLOCKS HAD CRACKS IN THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24752727 ↗MalfunctionApr 1, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE PATELLA CLAMPS WOULD NOT HOLD ATTACHMENTS. THE SPACER BLOCKS HAD CRACKS IN THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24752659 ↗MalfunctionDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SPRING FROM THE PATELLA CLAMP WAS MISSING. THE EVENT DID NOT HAPPEN DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23851699 ↗MalfunctionDec 18, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATELLA HEAD SLIDES OFF THE CLAMP BECAUSE THE JOINT HOLDING IT IN PLACE WAS WORN OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23842748 ↗MalfunctionNov 21, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATELLA CLAMP WAS NOT LOCKING CORRECTLY AND WOULD NOT STAY STRAIGHT WHEN THE DRUM WAS INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23616639 ↗MalfunctionOct 23, 2025Break; Break
IT WAS REPORTED THAT THE PATELLA CLAMP WAS BROKEN. THE EVENT DID NOT HAPPENED DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23373972 ↗MalfunctionAug 20, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE MODULAR PATELLA CLAMP DID NOT HOLD THE RUBBER PIECE IN THE CLAMP. THERE WAS NO DELAY AND NO HARM TO PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22854056 ↗MalfunctionJun 20, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THERE WAS AN ALLEGATION REPORTED ON INSTRUMENT'S SPRING. UPON MANUFACTURER'S INVESTIGATION IT WAS NOTED THAT A COMPONENT WAS MISSING FROM THE INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22299335 ↗MalfunctionJun 3, 2025Break; Break
IT WAS REPORTED THAT THE SPRING BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22133901 ↗MalfunctionMay 30, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BLADE GOT STUCK ON THE MEDIUM PATELLA REAMER AND DID NOT COME OFF. THE RED KNOB ON THE SIDE OF THE ATTUNE FEMORAL INTRODUCER FELL OFF WHEN IMPACTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22114533 ↗MalfunctionMay 30, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BLADE GOT STUCK ON THE MEDIUM PATELLA REAMER AND DID NOT COME OFF. THE RED KNOB ON THE SIDE OF THE ATTUNE FEMORAL INTRODUCER FELL OFF WHEN IMPACTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22114526 ↗MalfunctionFeb 19, 2025Break; Break
IT WAS REPORTED THAT AS TECH WAS TRYING TO SEPARATE THE PATELLA CLAMP IMPLANT, THE TOP PORTION OF THE ORANGE IMPACTOR CHIPPED OFF PRETTY BADLY. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21412633 ↗MalfunctionFeb 7, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE CUTTING BLOCK HAS JAGGED EDGES ON THE BACK OF IT. THE PATELLA CLAMP WILL NOT SECURELY ACCEPT ATTACHMENTS. SURGICAL DELAY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21337772 ↗
Other Depuy Orthopaedics, Inc. products
- PINNACLE ALTRX98 models · 5,631 reports
- BIOLOX DELTA40 models · 4,995 reports · 1 recall
- PINNACLE182 models · 4,587 reports
- QUICKSET7 models · 3,790 reports
- PINNACLE POROCOAT38 models · 2,112 reports
- SUMMIT POROCOAT20 models · 1,646 reports
- PINNACLE GRIPTION57 models · 1,608 reports
- DURALOC93 models · 1,262 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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