Comprehensive ProlongRecalls & reported problems across all models
Zimmer, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 53
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls
- 0
We found 6 models of Comprehensive Prolong by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 53 adverse event reports in the FDA's MAUDE database, received between Jun 4, 2020 and Aug 5, 2026 — classified as 50 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (28 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 Comprehensive Prolong problems
Device problems
- Device Dislodged or Dislocated28
- Detachment of Device or Device Component22
- Adverse Event Without Identified Device or Use Problem7
- Fracture2
- Naturally Worn2
- Unintended Movement2
- Device Contaminated During Manufacture or Shipping1
- Noise, Audible1
Patient problems
- Joint Dislocation24
- Failure of Implant20
- Insufficient Information7
- Pain5
- No Clinical Signs, Symptoms or Conditions4
- Joint Laxity3
- Joint Impingement2
- Adhesion(s)1
Comprehensive Prolong models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Comprehensive® Prolong® 110031418prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented20 reports
- Comprehensive® Prolong® 110031421shoulder prosthesis, reverse configuration20 reports
- Comprehensive® Prolong® 110031422PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED5 reports
- Comprehensive® Prolong® 110031419PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Comprehensive® Prolong® 110031423shoulder prosthesis, reverse configuration3 reports
- Comprehensive® Prolong® 110031420shoulder prosthesis, reverse configuration1 report
Recent Comprehensive Prolong adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 5, 2026Detachment of Device or Device Component; Device Dislodged or Dislocated; Noise, Audible
It was reported that a revision was performed due to polyethylene dissociation, noted as the second such event within approximately two (2) years. The surgical technique used during the initial procedure was followed. Attempts have been made and no further information has been provided.
Patient problems: Crepitus; Insufficient Information; Joint Dislocation
MAUDE report 50143345 ↗InjuryMar 31, 2026Device Dislodged or Dislocated
No further event information available at the time of this report.
Patient problems: Joint Dislocation
MAUDE report 24741709 ↗InjuryDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Laxity
MAUDE report 23769790 ↗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 ↗InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY ELEVEN (11) MONTHS AGO. SUBSEQUENTLY, THERE HAS BEEN AN ALLEGED UNKNOWN COMPLICATION WITH NO KNOWN INTERVENTION TO DATE. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 22370959 ↗InjuryMay 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT UNDERWENT A CLOSED REDUCTION UNDER SEDATION APPROXIMATELY 5 MONTHS POST IMPLANTATION DUE TO DISLOCATION. THE PATIENT HAD REPORTED PAIN AFTER UNDERGOING A LUMBAR KYPHOPLASTY, AND AN X RAY THE SAME DAY CONFIRMED THE DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation; Pain
MAUDE report 22051497 ↗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 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED FROM A CLINICAL STUDY THAT A PATIENT HAD A RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY PERFORMED. THE PATIENT DID VERY WELL THROUGHOUT THE STUDY UNTIL REPORTING SEVERE PAIN AND INSTABILITY WITH ACTIVITIES AT THE 5 YEAR FOLLOW UP. THERE WAS NO SPECIFICISSUES FOUND WITH THE IMPLANT NOR DID THE PATIENT HAVE ANY TRAUMA. THERE IS NO PLANNED REVISION SURGERY. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Pain
MAUDE report 21731758 ↗InjuryMar 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE DISLOCATION. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 21730570 ↗InjuryMar 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT HAS HAD A HISTORY OF MULTIPLE REVISIONS OF THEIR RIGHT REVERSE TOTAL SHOULDER THAT WAS INITIALLY IMPLANTED APPROXIMATELY 6 YEARS AGO. AFTER RECEIVING A NEW REVERSE SHOULDER APPROXIMATELY 2 MONTHS AGO, THE PATIENT WAS REVISED AGAIN 1 MONTH AGO DUE TO DISLOCATION. THE BASEPLATE WAS RETAINED AND ALL OTHER COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 21645211 ↗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 ↗InjuryFeb 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISASSOCIATION OF THE POLY FROM THE HUMERAL TRAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Adhesion(s); Failure of Implant; Joint Laxity; Joint effusion; Muscle/Tendon Damage; Pain
MAUDE report 21375006 ↗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 ↗InjuryJan 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED ONE MONTH POST IMPLANTATION DUE TO DISASSOCIATION BETWEEN THE POLY AND THE HUMERAL TRAY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21159370 ↗
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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