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Comprehensive® Reverse Shoulder 180551Recalls & reported problems

Biomet Orthopedics, LLC · Class 2

Quick summary

This Biomet Comprehensive reverse shoulder implant is a semi-constrained shoulder replacement used in total shoulder procedures. The 43 reports mostly describe pain and revision surgery years after implantation, along with bone fractures, loosening of the implant from the bone, erosion of the shoulder socket, and screws breaking or coming loose, sometimes with the implant coming apart. There were42 injuries and no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
42
Deaths reported
0
Injuries reported
41
Recalls naming it
0

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00880304677142), received between Nov 26, 2019 and Apr 1, 2026 — classified as 41 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (14 reports).

19 other recalls cover devices cleared under the same FDA submission (K080642, K130390, K132239); 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 2 reportsJun 2024: 0 reportsJul 2024: 4 reportsAug 2024: 0 reportsSep 2024: 2 reportsOct 2024: 1 reportsNov 2024: 1 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 2 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 2 reportsJul 2025: 1 reportsAug 2025: 2 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 3 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem19
  • Loosening of Implant Not Related to Bone-Ingrowth14
  • Fracture7
  • Noise, Audible3
  • Malposition of Device2
  • Material Erosion2
  • Detachment of Device or Device Component1
  • Insufficient Device Problem Information1

Patient problems

  • Pain15
  • Failure of Implant9
  • Bone Fracture(s)8
  • Erosion7
  • Aseptic loosening4
  • Insufficient Information3
  • Limited Mobility Of The Implanted Joint3
  • Deformity/ Disfigurement2

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 1, 2026Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 DAYS POST IMPLANTATION DUE TO A POORLY FIXATED AND LOOSENED CENTRAL SCREW. THE SURGEON STATED THE CENTRAL SCREW WAS TOO SHORT AND NOT BICORTICAL AND ACCEPTED THIS AS SURGEON ERROR. THE SURGEON ALSO REPORTED THE PATIENT HAD POOR BONE QUALITY AND AVASCULAR NECROSIS, WHICH MAY HAVE CONTRIBUTED TO THE FAILURE, AND WAS UNSURE IF A LONGER BICORTICAL CENTRAL SCREW WOULD HAVE PREVENTED THE LOOSENING FAILURE. THE PATIENT WAS REVISED BY REMOVING THE GLENOID/BASEPLATE AND CONVERTING TO A HEMIARTHROPLASTY. THE HUMERAL STEM REMAINED IN SITU. NO ADDITIONAL PATIENT OUTCOME INFORMATION WAS PROVIDED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Aseptic loosening; Pain

    MAUDE report 24757194 ↗
  • InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED PATIENT UNDERWENT REVISION USING A CUSTOM IMPLANT APPROXIMATELY 1 YEAR AND 1 MONTH POST IMPLANTATION DUE TO THE PATIENT'S GLENOID BONE FRACTURING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Patient problems: Bone Fracture(s)

    MAUDE report 24415306 ↗
  • InjuryNov 21, 2025Fracture; Fracture

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER IMPLANTATION ON AN UNKNOWN DATE APPROXIMATELY THREE (3) YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO FRACTURED SCREWS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Insufficient Information

    MAUDE report 23616453 ↗
  • InjuryNov 20, 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 AN LEFT TOTAL SHOULDER. SUBSEQUENTLY, THE PATIENT HAS REPORTED AN INCREASE IN SHOULDER PAIN, AT TIMES SEVERE, WITH AN ONSET DATE OF APPROXIMATELY 6 YEARS POSTOP. IT IS UNKNOWN IF REVISION SURGERY IS RECOMMENDED OR PLANNED. NO INTRAOPERATIVE COMPLICATIONS. NO FURTHER INFORMATION REGARDING TREATMENT OR INTERVENTION HAS BEEN PROVIDED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Pain

    MAUDE report 23610477 ↗
  • InjuryNov 20, 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 AN LEFT TOTAL SHOULDER. SUBSEQUENTLY, THE PATIENT HAS REPORTED AN INCREASE IN SHOULDER PAIN, AT TIMES SEVERE, WITH AN ONSET DATE OF APPROXIMATELY 6 YEARS POSTOP. IT IS UNKNOWN IF REVISION SURGERY IS RECOMMENDED OR PLANNED. NO INTRAOPERATIVE COMPLICATIONS. NO FURTHER INFORMATION REGARDING TREATMENT OR INTERVENTION HAS BEEN PROVIDED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Pain

    MAUDE report 23610475 ↗
  • InjuryAug 27, 2025Adverse 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 6 MONTHS POST IMPLANTATION DUE TO IMPLANT DISASSOCIATION AND MASSIVE GLENOID EROSION. THE PATIENT WAS CONVERTED TO A HEMIARTHROPLASTY AND WILL BE IMPLANTED WITH A CUSTOM BASEPLATE ON AN UNKNOWN DATE IN THE FUTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Patient problems: Erosion

    MAUDE report 22903789 ↗
  • InjuryAug 27, 2025Adverse 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 6 MONTHS POST IMPLANTATION DUE TO IMPLANT DISASSOCIATION AND MASSIVE GLENOID EROSION. THE PATIENT WAS CONVERTED TO A HEMIARTHOPLASTY AND WILL BE IMPLANTED WITH A CUSTOM BASEPLATE ON AN UNKNOWN DATE IN THE FUTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Patient problems: Erosion

    MAUDE report 22903772 ↗
  • InjuryJul 16, 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 ONE (1) YEAR AND SIX (6) MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY ONE (1) MONTH AGO DUE TO THE IMPLANTS LOOSENING. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

    Patient problems: Pain

    MAUDE report 22524273 ↗
  • InjuryJun 26, 2025Material Erosion; Material Erosion

    IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL ANATOMICAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE WITH UNKNOWN PRODUCTS. APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS AGO, THE PATIENT WAS REVISED TO A COMPREHENSIVE REVERSE TOTAL SHOULDER ARTHROPLASTY DUE TO GLENOID LOOSENING AND FAILED ROTATOR CUFF. SUBSEQUENTLY, THE PATIENT HAD FALLEN APPROXIMATELY ONE (1) YEAR AND FOUR (4) MONTHS POST-IMPLANTATION AND THEN BEGAN TO HAVE PAIN. RADIOGRAPHIC IMAGING DISPLAYED MALALIGNMENT OF THE GLENOSPHERE, FRACTURED SCREW, LUCENCY AROUND THE INFERIOR LOCKING SCREW, RADIO-DENSE BODIES SUPERIOR IN THE JOINT, AND LIKELY BONY FRAGMENTS INFERIORLY. APPROXIMATELY ONE (1) MONTH AGO, THE PATIENT UNDERWENT A REVISION WHERE A LITTLE BIT OF METALLOSIS OF THE SOFT TISSUE AROUND THE JOINT CAPSULE WAS ENCOUNTERED AND THE CENTRAL SCREW WAS FRACTURED. CANCELLOUS ALLOGRAFT WAS IMPLANTED AND THE PATIENT WAS CONVERTED TO A HEMIARTHROPLASTY WITH PLANS FOR A POSSIBLE REVISION IN THE FUTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Aseptic loosening; Metal Related Pathology; Pain; Radiolucent Lines

    MAUDE report 22342446 ↗
  • InjuryJun 26, 2025Material Erosion; Material Erosion

    IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL ANATOMICAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE WITH UNKNOWN PRODUCTS. APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS AGO, THE PATIENT WAS REVISED TO A COMPREHENSIVE REVERSE TOTAL SHOULDER ARTHROPLASTY DUE TO GLENOID LOOSENING AND FAILED ROTATOR CUFF. SUBSEQUENTLY, THE PATIENT HAD FALLEN APPROXIMATELY ONE (1) YEAR AND FOUR (4) MONTHS POST-IMPLANTATION AND THEN BEGAN TO HAVE PAIN. RADIOGRAPHIC IMAGING DISPLAYED MALALIGNMENT OF THE GLENOSPHERE, FRACTURED SCREW, LUCENCY AROUND THE INFERIOR LOCKING SCREW, RADIO-DENSE BODIES SUPERIOR IN THE JOINT, AND LIKELY BONY FRAGMENTS INFERIORLY. APPROXIMATELY ONE (1) MONTH AGO, THE PATIENT UNDERWENT A REVISION WHERE A LITTLE BIT OF METALLOSIS OF THE SOFT TISSUE AROUND THE JOINT CAPSULE WAS ENCOUNTERED AND THE CENTRAL SCREW WAS FRACTURED. CANCELLOUS ALLOGRAFT WAS IMPLANTED AND THE PATIENT WAS CONVERTED TO A HEMIARTHROPLASTY WITH PLANS FOR A POSSIBLE REVISION IN THE FUTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Aseptic loosening; Metal Related Pathology; Pain; Radiolucent Lines

    MAUDE report 22342442 ↗
  • InjuryMay 28, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS CONSIDERED FOR A PMI PRODUCT AND REVISED DUE TO LOOSENING AND INSTABILITY OF THE IMPLANT. DURING THE REVISION, IT WAS NOTED THAT THE CENTRAL SCREW WAS FRACTURED. ALL COMPONENTS WERE REMOVED AND REPLACED; HOWEVER, A PIECE OF THE FRACTURED CENTRAL SCREW COULD NOT BE REMOVED AS IT WAS RETAINED IN THE GLENOID.

    Patient problems: Aseptic loosening

    MAUDE report 22101936 ↗
  • InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT WAS REVISED FOUR MONTHS POST INITIAL IMPLANTATION DUE TO SCAPULAR FRACTURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Patient problems: Bone Fracture(s)

    MAUDE report 21504806 ↗
  • InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS GETTING DRESSED AND FELT A POPPING SENSATION WHICH LED TO THE REVISION PROCEDURE.

    Patient problems: Bone Fracture(s)

    MAUDE report 21504802 ↗
  • InjuryFeb 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A LOOSENING OF THE DEVICE. THERE WAS HARM OR INJURY TO PATIENT AS THE PATIENT HAD TO UNDERGO ADDITIONAL SURGICAL PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Failure of Implant

    MAUDE report 21369877 ↗
  • 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 20831435 ↗
  • InjuryNov 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: Failure of Implant

    MAUDE report 20611795 ↗
  • InjuryOct 1, 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

    MAUDE report 20346590 ↗
  • InjurySep 27, 2024Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT A PATIENT EXPERIENCED BASEPLATE LOOSENING FROM THE GLENOID FOLLOWING AN INITIAL ARTHROSCOPY PROCEDURE. THE SURGEON INDICATED THE PATIENT'S ANATOMY, WITH VERY LITTLE BONE IN THE GLENOID, LIKELY CAUSED THE FAILURE. IMAGING CONFIRMED THIS LOOSENING APPROXIMATELY FIFTEEN (15) MONTHS LATER. ADDITIONALLY, ONE (1) OF THE PERIPHERAL SCREWS WAS FOUND TO BE FRACTURED DURING RADIOGRAPH EVALUATION. A FUTURE REVISION IS PLANNED ON AN UNKNOWN DATE. NO OTHER INTERVENTIONS OR HARMS HAVE BEEN REPORTED DUE TO THIS EVENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Deformity/ Disfigurement

    MAUDE report 20321576 ↗
  • InjurySep 27, 2024Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT A PATIENT EXPERIENCED BASEPLATE LOOSENING FROM THE GLENOID FOLLOWING AN INITIAL ARTHROSCOPY PROCEDURE. THE SURGEON INDICATED THE PATIENT'S ANATOMY, WITH VERY LITTLE BONE IN THE GLENOID, LIKELY CAUSED THE FAILURE. IMAGING CONFIRMED THIS LOOSENING APPROXIMATELY FIFTEEN (15) MONTHS LATER. ADDITIONALLY, ONE (1) OF THE PERIPHERAL SCREWS WAS FOUND TO BE FRACTURED DURING RADIOGRAPH EVALUATION. A FUTURE REVISION IS PLANNED ON AN UNKNOWN DATE. NO OTHER INTERVENTIONS OR HARMS HAVE BEEN REPORTED DUE TO THIS EVENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Deformity/ Disfigurement

    MAUDE report 20321556 ↗
  • InjuryJul 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: Insufficient Information

    MAUDE report 19798019 ↗
  • InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THE UNDERWENT A RIGHT SHOULDER REPLACEMENT APPROXIMATELY 2 MONTHS AGO. THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM AND IMAGING REVEALED THAT THE BASEPLATE, SCREWS, AND GLENOSPHERE HAD MIGRATED OUT OF THE PATIENT'S GLENOID, SECONDARY TO FRACTURE. THE SURGEON INDICATED THE FRACTURE LIKELY WAS FROM THE PRIMARY PROCEDURE. THEREFORE, THE PATIENT WAS REVISED APPROXIMATELY 3 WEEKS AGO DUE TO A BONE FRACTURE. THE HUMERAL STEM, HUMERAL TRAY, AND HUMERAL BEARING REMAINED IN SITU. THE SURGEON DEEMED THE GLENOID TO BE UNSALVAGEABLE DUE TO THE FRACTURE. THEREFORE, THE SURGEON PACKED THE GLENOID WITH SYNTHETIC BONE GRAFT AND USED A MINI HUMERAL TRAY AND BEARING WITH AN OVERSIZED HUMERAL HEAD FOR SALVAGE HEMI-ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Patient problems: Bone Fracture(s)

    MAUDE report 19643186 ↗
  • InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THE UNDERWENT A RIGHT SHOULDER REPLACEMENT APPROXIMATELY 2 MONTHS AGO. THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM AND IMAGING REVEALED THAT THE BASEPLATE, SCREWS, AND GLENOSPHERE HAD MIGRATED OUT OF THE PATIENT'S GLENOID, SECONDARY TO FRACTURE. THE SURGEON INDICATED THE FRACTURE LIKELY WAS FROM THE PRIMARY PROCEDURE. THEREFORE, THE PATIENT WAS REVISED APPROXIMATELY 3 WEEKS AGO DUE TO A BONE FRACTURE. THE HUMERAL STEM, HUMERAL TRAY, AND HUMERAL BEARING REMAINED IN SITU. THE SURGEON DEEMED THE GLENOID TO BE UNSALVAGEABLE DUE TO THE FRACTURE. THEREFORE, THE SURGEON PACKED THE GLENOID WITH SYNTHETIC BONE GRAFT AND USED A MINI HUMERAL TRAY AND BEARING WITH AN OVERSIZED HUMERAL HEAD FOR SALVAGE HEMI-ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Patient problems: Bone Fracture(s)

    MAUDE report 19643177 ↗
  • InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THE UNDERWENT A RIGHT SHOULDER REPLACEMENT APPROXIMATELY 2 MONTHS AGO. THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM AND IMAGING REVEALED THAT THE BASEPLATE, SCREWS, AND GLENOSPHERE HAD MIGRATED OUT OF THE PATIENT'S GLENOID, SECONDARY TO FRACTURE. THE SURGEON INDICATED THE FRACTURE LIKELY WAS FROM THE PRIMARY PROCEDURE. THEREFORE, THE PATIENT WAS REVISED APPROXIMATELY 3 WEEKS AGO DUE TO A BONE FRACTURE. THE HUMERAL STEM, HUMERAL TRAY, AND HUMERAL BEARING REMAINED IN SITU. THE SURGEON DEEMED THE GLENOID TO BE UNSALVAGEABLE DUE TO THE FRACTURE. THEREFORE, THE SURGEON PACKED THE GLENOID WITH SYNTHETIC BONE GRAFT AND USED A MINI HUMERAL TRAY AND BEARING WITH AN OVERSIZED HUMERAL HEAD FOR SALVAGE HEMI-ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Patient problems: Bone Fracture(s)

    MAUDE report 19643167 ↗
  • InjuryMay 21, 2024Fracture; Fracture

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: Insufficient Information

    MAUDE report 19363351 ↗
  • InjuryMay 21, 2024Fracture; Fracture

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: Bacterial Infection; Failure of Implant; Pain

    MAUDE report 19358850 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080642, K130390, K132239. One submission often covers many models, so check the product and lot details in each record.

  • Z-1131-2021 · Jan 15, 2021 · Terminated
    Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
  • Z-0619-2021 · Nov 25, 2020 · Terminated
    Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 1805
  • Z-2144-2020 · Apr 17, 2020 · Terminated
    Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comp
  • Z-1750-2020 · Mar 13, 2020 · Terminated
    Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the gle
  • Z-1859-2017 · Feb 17, 2017 · Terminated
    various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Sh
  • Z-1103-2017 · Dec 20, 2016 · Terminated
    Comprehensive Reverse Shoulder System Humeral Tray Model 115340
  • Z-1548-2013 · May 15, 2013 · Terminated
    Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
  • Z-2547-2011 · Apr 22, 2011 · Terminated
    Custom solar comprehensive reverse humeral tray with lock ring 44 mm +5mm, sterile, REF CP561659, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder product
  • Z-2545-2011 · Apr 22, 2011 · Terminated
    Comprehensive reverse shoulder humeral tray with locking ring, 44 mm standard, sterile, single use, REF 115340, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Sho
  • Z-2550-2011 · Apr 22, 2011 · Terminated
    Custom comprehensive reverse shoulder bio-modular base 44 mm humeral tray standard, REF CP561510, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder product
  • Z-2549-2011 · Apr 22, 2011 · Terminated
    Custom comprehensive reverse humeral tray set w/ lock rings 44 mm + 15 mm & + 18 mm sterile, REF CP561705, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder
  • Z-2542-2011 · Apr 22, 2011 · Terminated
    Bio-modular reverse shoulder humeral tray with lock ring, 44 mm standard, sterile, single use, REF 11-113680, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder
  • Z-2544-2011 · Apr 22, 2011 · Terminated
    Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +5 mm, sterile, single use, REF 115345, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulde
  • Z-2543-2011 · Apr 22, 2011 · Terminated
    Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +10 mm, sterile, single use, REF 115348, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Should
  • Z-2541-2011 · Apr 22, 2011 · Terminated
    Bio-modular reverse shoulder humeral tray with lock ring, 44 mm 10 degree angle, sterile, single use, REF 11-113685, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse S

…and 4 more.

Other prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented devices

All prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.