Comprehensive® Prolong® 110031423Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
All models of Comprehensive Prolong (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887868231544), received between Jun 23, 2023 and Oct 23, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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
- Device Dislodged or Dislocated2
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Naturally Worn1
Patient problems
- Joint Dislocation2
- Failure of Implant1
- Insufficient Information1
- Joint Impingement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SHOULDER ARTHROPLASTY APPROXIMATELY TWO (2) MONTHS AGO DUE TO INSTABILITY. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION TO INCREASE CONSTRAINT ON AN UNKNOWN DATE. A CUSTOM IMPLANT REQUEST WAS SUBMITTED TO A COMPETITOR TO REPLACE ALL CURRENT IMPLANTS EXCEPT THE STEM AND GLENOID BASEPLATE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20515474 ↗InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED BY THE PMI GROUP THAT A PATIENT UNDERWENT THEIR SECOND REVISION APPROXIMATELY FIVE (5) MONTHS POST-IMPLANTATION DUE TO CHRONIC DISLOCATION CAUSED BY THE HUMERAL COMPONENT COMING IN CONTACT WITH THE VRS. DURING THIS PROCEDURE, THE POLY AND GLENOSPHERE WERE EXCHANGED AND THE VRS COMPONENT REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation; Joint Impingement
MAUDE report 19116185 ↗InjuryJun 23, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Naturally Worn; Detachment of Device or Device Component; Device Dislodged or Dislocated; Naturally Worn
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 17189675 ↗
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- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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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