Comprehensive® Prolong® 110031421Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
All models of Comprehensive Prolong (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00887868231520), received between Dec 14, 2020 and Oct 15, 2025 — classified as 19 injuries, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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
- Detachment of Device or Device Component12
- Device Dislodged or Dislocated9
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Naturally Worn1
- Unintended Movement1
- Unsealed Device Packaging1
- Unstable1
Patient problems
- Failure of Implant10
- Joint Dislocation6
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
- Joint Impingement1
- Joint Laxity1
- Loss of Range of Motion1
- Metal Related Pathology1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Unintended Movement; Detachment of Device or Device Component; Device Dislodged or Dislocated; Unintended Movement
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY 7 MONTHS POST-IMPLANTATION DUE TO LINER DISASSOCIATION. DURING FOLLOW-UP, LINER DISASSOCIATION WAS SUSPECTED AND A REVISION WAS SCHEDULED. INTRA-OPERATIVELY, THE LINER WAS FOUND LOOSE WITHIN THE CAPSULE AND WAS EASILY REMOVED WITH FORCEPS. THE TRAY WAS REMOVED AS WELL. THE GLENOSPHERE SHOWED NO APPARENT DAMAGE. TRIALING WAS PERFORMED WITH A +0 LINER, AFTER WHICH A +3 LINER WAS REQUESTED FOR RE-IMPLANTATION, AND THE WOUND WAS CLOSED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23294158 ↗InjuryAug 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Loss of Range of Motion; Metal Related Pathology; Pain; Subluxation
MAUDE report 22868438 ↗InjuryApr 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 21876849 ↗InjuryMar 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT HAS HAD A HISTORY OF MULTIPLE REVISIONS OF A RIGHT REVERSE SHOULDER THAT WAS INITIALLY IMPLANTED APPROXIMATELY 6 YEARS AGO. THE MOST RECENT REVISION OCCURRED APPROXIMATELY 1 MONTH AGO, AND THE PATIENT WAS SCHEDULED TO HAVE ANOTHER REVISION DUE TO DISLOCATION APPROXIMATELY 2 WEEKS AGO; HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 21642434 ↗InjuryJan 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED TWO MONTHS POST IMPLANTATION DUE TO DISASSOCIATION BETWEEN THE POLY AND THE HUMERAL TRAY. THE POLY WAS ONLY REVISED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21167745 ↗InjuryOct 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISASSOCIATION OF POLY FROM TRAY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 20438576 ↗InjuryJun 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 19459842 ↗InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED BY THE PMI GROUP THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY TWO (2) MONTHS POST-IMPLANTATION DUE TO DISLOCATION CAUSED BY THE HUMERAL COMPONENT COMING IN CONTACT WITH THE VRS. DURING THE PROCEDURE, THE POLY WAS EXCHANGED AND THE GLENOSPHERE AND VRS COMPONENTS REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation; Joint Impingement
MAUDE report 19116290 ↗InjuryJan 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A REVERSE ARTHROPLASTY REVISION PROCEDURE WAS NEEDED DUE TO POLY LOOSENING IN THE JOINT APPROXIMATELY ONE (1) YEAR AND EIGHT (8) MONTHS AFTER INITIAL IMPLANTATION. NO OTHER INJURIES WERE REPORTED DUE TO THIS DISASSOCIATION, AND MEDICAL RECORDS ARE UNAVAILABLE FOR REVIEW. THE REVISION SURGERY WAS SUCCESSFUL WITHOUT ANY COMPLICATIONS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 18425765 ↗InjuryDec 13, 2023Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. UPON EXAMINATION AND CURRENT XRAY, IT WAS NOTED THAT THE REVERSE LINER HAD DISASSOCIATED FROM ITS TRAY AND WAS THE CAUSE THE INSTABILITY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18320654 ↗MalfunctionSep 7, 2023Unsealed Device Packaging; Unsealed Device Packaging
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17698027 ↗InjuryMay 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16984642 ↗InjuryMar 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16590097 ↗InjuryMar 9, 2023Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component
IT WAS REPORTED PATIENT UNDERWENT RIGHT SHOULDER REVISION DUE TO INSTABILITY. DURING THE PROCEDURE, THE HUMERAL BEARING WAS DISASSOCIATED WITH THE HUMERAL TRAY. THE BEARING, HUMERAL TRAY AND GLENOSPHERE WERE REMOVED AND REPLACED. NO PIECES WERE RETAINED BY THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 16517294 ↗InjuryFeb 15, 2023Fracture; Detachment of Device or Device Component; Device Dislodged or Dislocated; Fracture; Detachment of Device or Device Component; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 16378036 ↗InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 1 MONTH POSTIMPLANTATION DUE TO UNKNOWN REASONS. THE TRAY, BEARING, AND GLENOSPHERE WERE REVISED. 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 13824908 ↗InjuryJan 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TWO MONTHS POSTIMPLANTATION DUE TO THE POLY DISASSOCIATING FROM THE HUMERAL TRAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 13257505 ↗InjuryFeb 17, 2021Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 11337822 ↗InjuryDec 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 11020400 ↗InjuryDec 14, 2020Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 11003380 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page