Comprehensive® Prolong® 110031418Recalls & 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
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00887868231490), received between Jun 4, 2020 and Aug 5, 2026 — classified as 18 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated12
- Detachment of Device or Device Component6
- Adverse Event Without Identified Device or Use Problem3
- Device Contaminated During Manufacture or Shipping1
- Noise, Audible1
- Positioning Failure1
- Unintended Movement1
Patient problems
- Joint Dislocation11
- Failure of Implant6
- Insufficient Information3
- Pain2
- Adhesion(s)1
- Bone Fracture(s)1
- Crepitus1
- Joint Laxity1
Recent adverse event reports
The 20 most recent of 20 reports, 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 ↗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 ↗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 ↗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 ↗InjuryNov 19, 2024Detachment 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: Failure of Implant
MAUDE report 20727598 ↗InjuryOct 1, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: Joint Dislocation
MAUDE report 20345951 ↗InjurySep 30, 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 20333527 ↗InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY A MONTH AGO. SUBSEQUENTLY, 2 DAYS LATER THE PATIENT DEVELOPED PNEUMONIA AND PULMONARY EMBOLISM. MEDICAL TREATMENT INCLUDED ANTIBIOTICS, ANTICOAGULANTS, AND OXYGEN. THE ISSUE WAS RESOLVED 13 DAYS LATER. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Patient problems: Pneumonia; Pulmonary Embolism
MAUDE report 18902600 ↗InjuryJan 16, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT SHOULDER REVISION DUE TO DISASSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Insufficient Information; Joint Dislocation
MAUDE report 18518473 ↗InjuryMay 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 16951900 ↗InjuryNov 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY FOUR (4) MONTHS LATER THE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE IMPLANTS DISLOCATING.
Patient problems: Joint Dislocation
MAUDE report 15761329 ↗InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO DUE TO THE IMPLANT SUBLUXATION AND A BONE FRACTURE. THE PATIENT HAS BEEN REVISED ONE PREVIOUS TIME DUE TO BONE FRACTURE.
Patient problems: Bone Fracture(s); Failure of Implant
MAUDE report 14552947 ↗InjuryApr 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY SIX (6) WEEKS POST-IMPLANTATION DUE TO DISASSOCIATION OF THE POLY BEARING AND HUMERAL TRAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 14141010 ↗InjuryApr 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A SURGERY HAD BEEN PERFORMED WITH NORMAL TECHNIQUES AND WITHIN TWO WEEKS, THE HUMERAL BEARING BECAME DETACHED FROM HUMERAL TRAY. UPON REVISION, BEARING WAS MOVING FREELY AND BOTH HUMERAL TRAY AND GLENOSPHERE WERE PROPERLY SEATED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME,
Patient problems: Failure of Implant
MAUDE report 14116438 ↗MalfunctionMar 14, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13758344 ↗InjuryAug 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT WAS REVISED 17 DAYS POSTIMPLANTATION DUE TO SHOULDER DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 12347407 ↗InjuryJul 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: Joint Dislocation
MAUDE report 12198056 ↗MalfunctionJun 4, 2020Positioning Failure; Positioning Failure
IT WAS REPORTED THE DOCTOR PUT THE HUMERAL TRAY AND HUMERAL BEARING TOGETHER PER SURGICAL TECHNIQUE. THE HUMERAL TRAY AND HUMERAL BEARING SNAPPED TOGETHER WITH NO PROBLEM. THE DOCTOR IMPACTED THE HUMERAL TRAY AND HUMERAL BEARING COMPONENT ONTO HUMERAL STEM. AS DOCTOR WAS REDUCING SHOULDER, THE HUMERAL BEARING DISENGAGED FROM HUMERAL TRAY. THE DOCTOR REMOVED THE HUMERAL BEARING AND HUMERAL TRAY. INSPECTED THEM ON THE BACK TABLE AND TRIED PUTTING THE COMPONENTS BACK TOGETHER AGAIN. THE HUMERAL TRAY AND HUMERAL BEARING SEPARATED EASILY. THE DOCTOR THEN OPENED NEW COMPONENTS AND IMPLANTED THEM WITH NO PROBLEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10120952 ↗
Other prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented devices
- Comprehensive Reverse Shoulder 115310Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death99 reports
- INHANCE 5120-00-110Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented75 reports
- Comprehensive® Reverse Shoulder XL-115364Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall7 reports
- Comprehensive® Reverse Shoulder XL-115366Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall4 reports
- Comprehensive® Reverse Shoulder 180550Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 deaths43 reports
- DJO SURGICAL 521-07-246Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- Comprehensive® Reverse Shoulder 180551Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- Comprehensive® 110031399Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death36 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.
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