COMPREHENSIVE® REVERSE SHOULDER 110032420Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00880304993242), received between Jul 8, 2021 and Sep 23, 2026 — classified as 19 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 reports).
1 other recall cover devices cleared under the same FDA submission (K172502); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component8
- Adverse Event Without Identified Device or Use Problem4
- Loosening of Implant Not Related to Bone-Ingrowth4
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
- Malposition of Device1
- Migration1
- Unintended Movement1
Patient problems
- Failure of Implant7
- Pain4
- No Clinical Signs, Symptoms or Conditions3
- Osteopenia/ Osteoporosis3
- Bone Fracture(s)2
- Insufficient Information2
- Bacterial Infection1
- Extraskeletal ossification1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Detachment of Device or Device Component
It was reported the patient had a reverse shoulder system implanted. Approximately, 4 months post-operation, the patient reported increasing pain over the last 6 weeks to the surgeon. X-rays confirmed the broken screws and baseplate and taper adapted disassociation. Future revision surgery plan and date unknown. It was reported that no further information is available.
Patient problems: Pain
MAUDE report 50868970 ↗InjurySep 2, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566672 ↗InjuryDec 18, 2025Migration; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY REVERSE SHOULDER PROCEDURE. SUBSEQUENTLY, APPROXIMATELY 5 MONTHS AND 19 DAYS POST IMPLANTATION THE PATIENT WAS PRESENTING WITH A PAINFUL SHOULDER AND AN X-RAY AND CT SCAN SHOWED GLENOID COMPONENT MIGRATION. IT WAS NOTED THAT THE PATIENT HAD PRIOR NEUROLOGIC PATHOLOGY AND POOR BONE QUALITY. THE PATIENT PLANS TO BE REVISED WHERE THE GLENOID COMPONENTS WILL BE REMOVED WHILE DISCUSSING FURTHER OPTIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Pain
MAUDE report 23843542 ↗InjuryNov 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY FIVE (5) YEARS AND FIVE (5) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY ONE (1) MONTH AGO DUE TO THE IMPLANTS DISASSOCIATING. IT IS UNKNOWN AT THIS TIME WHAT CAUSED THE IMPLANTS TO DISASSOCIATE.
Patient problems: Failure of Implant
MAUDE report 23468660 ↗InjurySep 11, 2025Malposition of Device; Malposition of Device
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23031859 ↗InjuryApr 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY FIVE (5) YEARS AND THREE MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY A MONTH AGO DUE TO LOOSENING OF THE IMPLANTS. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 21855606 ↗InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bone Fracture(s)
MAUDE report 21504781 ↗InjuryJan 7, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT UNDERWENT A SHOULDER ARTHROPLASTY APPROXIMATELY ONE MONTH AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED 8 DAYS LATER DUE TO INSTABILITY AND LOOSENING. PATIENT HAD NEW STEM AND TAPER PUT IN. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 21095589 ↗InjuryDec 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20831423 ↗InjuryNov 1, 2024Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISASSOCIATION. IT WAS ALSO REPORTED THAT AN UNKNOWN AMOUNT OF SCREWS WERE LOOSE FROM THE BASE PLATE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 20587296 ↗InjuryAug 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE PATIENT UNDERWENT A LEFT TOTAL REVERSE TOTAL SHOULDER ARTHROPLASTY REVISION PROCEDURE APPROXIMATELY EIGHTEEN (18) MONTHS POST-IMPLANTATION DUE TO COMPONENT DISASSOCIATION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 20050654 ↗InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT WAS PRESCRIBED PAIN MEDICATION APPROXIMATELY 2.5 YEARS POST IMPLANTATION OF AN RTSA DUE TO CHRONIC SHOULDER PAIN. ALL DEVICES REMAIN IMPLANTED AND NO FURTHER INTERVENTION HAS OCCURRED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Pain
MAUDE report 19035609 ↗InjuryOct 20, 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; Insufficient Information
MAUDE report 17976282 ↗InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING AN INITIAL IMPLANTATION, THE SURGEON FRACTURED THE ANTERIOR CORTEX OF THE PATIENT'S GLENOID. SUBSEQUENTLY, THE SURGEON OPTED TO LEAVE THE PATIENT'S JOINT LOOSE IN ORDER TO ALLOW THE BONE TO HEAL WITH THE INTENTION OF REVISING THE PATIENT AT A LATER TIME TO RE-TENSION THE SHOULDER. THE PATIENT WAS REVISED APPROXIMATELY TWO (2) MONTHS LATER, WHERE A NEW GLENOSPHERE AND HUMERAL POLY WERE ALSO EXCHANGED TO PROVIDE ADDITIONAL STABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s); Extraskeletal ossification
MAUDE report 15598777 ↗InjuryJun 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY TWO (2) DAYS POST-IMPLANTATION DUE TO DISASSOCIATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Osteopenia/ Osteoporosis
MAUDE report 14777675 ↗InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 10 MONTHS POSTIMPLANTATION DUE TO INFECTION, PERSISTENT PAIN AND LOOSENING OF HARDWARE. ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. SIGNIFICANT DISCOLORED BIO-FILM TYPE TISSUE WAS PRESENT UPON REMOVAL OF THE HUMERAL TRAY. HUMERAL STEM WAS REMOVED WITHOUT SIGNIFICANT BONE LOSS, GLENOID REMOVED WITHOUT COMPLICATION. THE BASEPLATE WAS GROSSLY LOOSE PRIOR TO REMOVAL, WITH SIGNIFICANT BONE LOSS, SOFT TISSUE DEBRIDEMENT AND BIO-FILM TISSUE PRESENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Bacterial Infection; Osteopenia/ Osteoporosis; Pain
MAUDE report 14754313 ↗InjuryMar 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION APPROXIMATELY 1 MONTH POSTIMPLANTATION DUE TO A BASEPLATE/TAPER DISASSOCIATION WHICH CAUSED A DISPLACED GLENOSPHERE AND SECONDARY DAMAGE TO THE HUMERAL BEARING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 13656352 ↗InjuryMar 2, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY 1 YEAR AND 2 DAYS POST IMPLANTATION DUE TO A FOREIGN OBJECT IDENTIFIED ON POST OP RADIOGRAPHS. THE OBJECT WAS REMOVED AND ALL COMPONENTS WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 13653262 ↗InjuryJul 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A LEFT SHOULDER REVISION SURGERY APPROXIMATELY THREE (3) WEEKS AGO WHILE DURING A REVISION SURGERY FOR UNKNOWN REASON SURGEON WAS TRIALING THE BASE PLATE CAME OUT ALONG WITH GLENOSPHERE. IT WAS REPORTED BY THE SURGEON THAT THE PATIENT'S BONE WAS SOFT AND THAT THE REVISION WAS THEN CONVERTED TO A HEMIARTHROPLASTY.
Patient problems: Insufficient Information
MAUDE report 12134277 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K172502. One submission often covers many models, so check the product and lot details in each record.
- Z-0520-2020 · Aug 21, 2019 · TerminatedCOMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 CP561861 PM0001456 PM551047 PM551063 PM555137 PM5
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.