Pressure SentinelRecalls & reported problems across all models
Zimmer, Inc. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 11 models of Pressure Sentinel by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Oct 1, 2020 and Aug 3, 2026 — classified as 7 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Fracture” (22 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 Pressure Sentinel problems
Device problems
- Fracture22
- Detachment of Device or Device Component7
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Foreign Body In Patient7
- No Consequences Or Impact To Patient1
Pressure Sentinel models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Pressure Sentinel® 2228-06INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT6 reports
- Pressure Sentinel® 2228-05INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT4 reports
- Pressure Sentinel® 2228-07INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT4 reports
- Pressure Sentinel® 2228-08INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT4 reports
- Pressure Sentinel® 2218-12INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2 reports
- Pressure Sentinel® 2228-11INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2 reports
- Pressure Sentinel® 2228-05-05INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
- Pressure Sentinel® 2228-08-05INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
- Pressure Sentinel® 2228-10INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
- Pressure Sentinel® 2228-10-05INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
- Pressure Sentinel® 2228-18INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
Recent Pressure Sentinel adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114533 ↗MalfunctionJun 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE END OF THE REAMER DISASSEMBLED DURING A PROCEDURE. THERE WAS NO REPORTED PATIENT HARM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22293703 ↗MalfunctionFeb 25, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE INSTRUMENT IT FRACTURED. THERE WAS NO FOREIGN BODY RETAINED OR HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21457975 ↗InjuryJan 29, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 21267926 ↗InjuryDec 2, 2024Fracture; Fracture
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: Foreign Body In Patient
MAUDE report 20820907 ↗InjuryNov 4, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL ELBOW PROCEDURE, THE FLEXIBLE REAMER INSTRUMENT FRACTURED. THE BROKEN DRILL HEAD WAS UNABLE TO BE REMOVED AND THE SURGEONS OPTED TO LEAVE THE FRAGMENT IN PLACE AS IT DID NOT INTERFERE WITH THE IMPLANT PLACEMENT. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 20602824 ↗InjuryOct 31, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 20578299 ↗MalfunctionOct 2, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20355817 ↗MalfunctionAug 15, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, THE REAMER HEAD FRACTURED WHILE REAMING THE CANAL. THE CORRECT SURGICAL TECHNIQUE WAS USED. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19994292 ↗MalfunctionMay 22, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19371187 ↗MalfunctionApr 23, 2024Fracture; Fracture
IT WAS REPORTED THAT THE REAMER BROKE DURING REAMING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19163250 ↗MalfunctionDec 22, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PRODUCT WAS FOUND TO BE FRACTURED UPON RECEIPT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18382565 ↗MalfunctionOct 10, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17904908 ↗MalfunctionSep 26, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17816544 ↗InjurySep 7, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 17699787 ↗
Other Zimmer, Inc. products
- PERSONA364 models · 2,000 reports · 3 recalls
- Persona The Personalized Knee77 models · 1,396 reports
- PERSONA Vivacit-E285 models · 1,152 reports
- NexGen198 models · 842 reports · 4 recalls
- Affixus18 models · 1 reports · 17 recalls
- PERSONA Natural Tibia25 models · 417 reports · 2 recalls
- NexGen Legacy119 models · 319 reports · 3 recalls
- Alliance32 models · 275 reports · 2 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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