Trabecular Metal® Vivacit-E® 00-4350-036-00Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024269392), received between Feb 10, 2020 and Oct 24, 2025 — classified as 6 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (5 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert5
- Device Dislodged or Dislocated4
- Device-Device Incompatibility1
- Material Deformation1
- Positioning Failure1
Patient problems
- Bone Fracture(s)4
- Joint Dislocation4
- No Clinical Signs, Symptoms or Conditions4
- Pain2
- Bone Notching1
- Loss of Range of Motion1
- Muscle Weakness/Atrophy1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER ON AN APPROXIMATELY FOUR (4) YEARS AND SEVEN (7) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY ONE (1) YEAR AND FIVE (5) YEARS AGO DUE TO INCREASED PAIN AND LOSS OF RANGE OF MOTION DUE TO THE IMPLANT DISASSOCIATING WITH CLAVICULAR NONUNION AND SCAPULAR MALALIGNMENT.
Patient problems: Bone Fracture(s); Bone Notching; Joint Dislocation; Loss of Range of Motion; Muscle Weakness/Atrophy; Nonunion/Delayed-union Bone Fracture; Osteolysis; Pain; Unequal Limb Length
MAUDE report 23378397 ↗InjuryMay 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL AN INITIAL LEFT SHOULDER ARTHROPLASTY APPROXIMATELY, SIX (6) YEARS AND NINE (9) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN AND DISLOCATION OF THE IMPLANTS.
Patient problems: Joint Dislocation; Pain
MAUDE report 22046812 ↗MalfunctionFeb 18, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO MATE A LINER INTO THE STEM EVEN THOUGH IT WAS HAMMERED APPROPRIATELY. ANOTHER LINER WAS ABLE TO MATE WITH THE SAME STEM AND THE SURGERY WAS COMPLETED. 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 21395642 ↗InjuryAug 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bone Fracture(s); Joint Dislocation
MAUDE report 20042712 ↗InjuryJul 3, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE TM REVERSE POLY DID NOT IMPACT ONTO STEM. SUBSEQUENTLY, A HUMERAL FRACTURE OCCURRED DUE TO THIS ISSUE. THE POLY WAS IMPACTED ONTO THE STEM ON THE BACK TABLE THEN RE-IMPLANTED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: Bone Fracture(s)
MAUDE report 17248662 ↗InjuryJul 3, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE TM REVERSE POLY DID NOT IMPACT ONTO STEM. SUBSEQUENTLY, A HUMERAL FRACTURE OCCURRED DUE TO THIS ISSUE. THE POLY WAS IMPACTED ONTO THE STEM ON THE BACK TABLE THEN RE-IMPLANTED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: Bone Fracture(s)
MAUDE report 17248656 ↗MalfunctionJun 29, 2023Difficult to Insert; Difficult to Insert
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17228075 ↗MalfunctionSep 8, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH TMRS SYSTEM AND DURING THE PROCEDURE THE TM LINER WAS NOT ABLE TO BE FIXED TO THE STEM. THE SURGEON TRIED TO JOIN IT REPEATEDLY, BUT IT WOULDN'T WORK. FINALLY, THE SURGERY WAS FINISHED WITH AN ALTERNATIVE LINER. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15379007 ↗InjuryJun 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY TWO AND A HALF (2.5) MONTHS POST-IMPLANTATION DUE TO DISLOCATION CAUSED BY OVERACTIVITY. ACCORDING TO THE SURGEON, THE PATIENT WAS MOWING HIS LAWN AND HAD A HARD JERKING MOTION THAT CAUSED THE DISLOCATION. THE GLENOSPHERE WAS UPSIZED AND A NEW RETENTIVE LINER WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 14631501 ↗MalfunctionSep 27, 2021Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation
IT WAS REPORTED THAT AN INITIAL PROCEDURE WAS PERFORMED APPROXIMATELY TWO AND A HALF (2.5) MONTHS AGO WHEN THE POLY LINER WAS UNABLE TO BE ASSEMBLED TO THE STEM DUE TO COSMETIC BURRS INTERFERING. A SECOND POLY LINER WAS USED TO COMPLETE THE SURGERY. PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12532756 ↗MalfunctionFeb 10, 2020Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON IMPACTED THE LINER TO THE STEM, BUT IT COULDN'T BE ASSEMBLED BECAUSE OF THE STEM'S INTERFERING PROJECTION. THEN HE OPENED A BACKUP LINER TO COMPLETE THE SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9686327 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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