Comprehensive Reverse Shoulder 010000589Recalls & reported problems

Summary

The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 00880304532465), received between Sep 30, 2019 and Sep 29, 2026 — classified as 134 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (81 reports).

1 FDA recall record name this device's identifier.

4 other recalls cover devices cleared under the same FDA submission (K120121, K193373); 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.

Recalls naming this device

1. Sep 2, 2020Terminated

   Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters

   Z-0093-2021 · Root cause: Packaging process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 142 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934095 ↗
• MalfunctionSep 21, 2026Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840739 ↗
• MalfunctionSep 9, 2026Flaked

  It was reported that during an initial implantation surgery, the baseplate and screws were inserted when it was discovered that fragments resembling an implant were noticed. The surgeon noted that the fragments appeared to have a jagged appearance similar to the porous coating from the edge of the baseplate. The baseplate was still implanted, but the fragments were removed and will be returning for investigation. No patient consequences were reported as a result of the event. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694773 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY ON AN UNKNOWN DAY FOR AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Insufficient Information; Pain

  MAUDE report 25679553 ↗
• InjuryJul 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THE GLENOSPHERE DISASSOCIATED FROM THE BASEPLATE. THE PATIENT UNDERWENT A REVISION PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25678331 ↗
• InjuryJun 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED A PATIENT HAD AN INITIAL REVERSE SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO COMPONENT DISASSOCIATION TWO (2) DAYS POST-OPERATION. NO ADDITIONAL COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REPORTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25537360 ↗
• InjuryJun 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIMARY REVERSE SHOULDER ARTHROPLASTY AND, AT A FOLLOW-UP VISIT APPROXIMATELY 7 WEEKS POST-IMPLANTATION, THE GLENOSPHERE WAS FOUND TO BE LOOSENED FROM THE BASEPLATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25409976 ↗
• InjuryJun 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GLENOSPHERE HEAD BECAME DISLODGED FOLLOWING A SHOULDER ARTHROPLASTY, NECESSITATING REOPERATION APPROXIMATELY THREE MONTHS POST-IMPLANTATION. DURING POSTOPERATIVE FOLLOW-UP, THE DISLODGEMENT WAS IDENTIFIED, AND DURING THE REOPERATION THE CENTRAL SCREW WAS RETIGHTENED AND THE GLENOSPHERE HEAD WAS REINSERTED. THE REPORTED CAUSE WAS THAT THE CENTRAL SCREW HAD NOT BEEN INSERTED TO A SUFFICIENT DEPTH DURING THE INITIAL SURGERY. THE PATIENT UNDERWENT REOPERATION WITH SUCCESSFUL COMPLETION OF THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 25391150 ↗
• InjuryMay 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL IMPLANTATION APPROXIMATELY TWO (2) YEARS AGO AND LATER UNDERWENT A REVISION ON APPROXIMATELY TEN (10) MONTHS IMPLANTATION DUE TO DISASSOCIATION OF THE TAPER AND BASEPLATE. SUBSEQUENTLY, THE PATIENT WAS REVISED AGAIN TWO (2) YEARS LATER DUE TO DISASSOCIATION OF THE TAPER AND BASEPLATE. DURING THE REVISION, A FAIR AMOUNT OF DEBRIS STAINING WAS NOTED WITHIN THE SYNOVIAL TISSUE, ALONG WITH SIGNIFICANT POLYETHYLENE WEAR ON THE MEDIAL SIDE. THE STEM AND BASEPLATE WERE RETAINED, ALL REMAINING IMPLANTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 25337374 ↗
• InjuryMay 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL IMPLANTATION APPROXIMATELY TWO (2) YEARS AGO AND LATER UNDERWENT A REVISION ON APPROXIMATELY TEN (10) MONTHS POST-IMPLANTATION DUE TO DISASSOCIATION OF THE TAPER AND BASEPLATE. DURING THE REVISION, THE TAPER AND BASEPLATE WERE REVISED. THE GLENOSPHERE, TRAY, AND BEARING WERE ALSO EXCHANGED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25337359 ↗
• InjuryMay 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TWO PREVIOUS REVISIONS APPROXIMATELY TWO (2) YEARS AGO FOR DISASSOCIATION AND APPROXIMATELY THREE (3) MONTHS AGO DUE TO DISASSOCIATION. SUBSEQUENTLY, THE PATIENT WAS REVISED A THIRD TIME APPROXIMATELY THREE (3) WEEKS AGO DUE TO DISASSOCIATION OF THE TAPER AND BASEPLATE. DURING THE REVISION, DARK SYNOVIAL STAINING AND EXTENSIVE METAL-COLORED FIBRINOUS MATERIAL, AS WELL AS POLYETHYLENE WEAR WAS NOTED. THE STEM AND BASEPLATE WERE STABLE AND THEREFORE RETAINED, ALL REMAINING IMPLANTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 25323382 ↗
• InjuryMay 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY SIX WEEKS POST-IMPLANTATION DUE TO COMPONENT DISSOCIATION. IT WAS DETERMINED BY THE SURGEON THAT THE CENTRAL SCREW HAD NOT BEEN SEATED PROPERLY DURING PRIMARY IMPLANTATION, WHICH EVENTUALLY CAUSED THE DISASSOCIATION OF THE GLENOSPHERE AND TAPER FROM THE BASEPLATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Crepitus

  MAUDE report 25160325 ↗
• MalfunctionApr 30, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DAMAGE TO THE DEVICE PACKAGING WAS DISCOVERED UPON OPENING PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044501 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT REVERSE TOTAL SHOULDER REVISION APPROXIMATELY 13 MONTHS POST-IMPLANTATION DUE TO IMPINGEMENT AND PAIN. DURING THE REVISION, NOTCH IMPINGEMENT WAS NOTED. THE GLENOSPHERE, HUMERAL TRAY, AND BEARING WERE EXCHANGED WITHOUT COMPLICATIONS, WHILE THE GLENOSPHERE BASEPLATE, FOUR SCREWS, AND HUMERAL STEM WERE RETAINED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Impingement; Pain

  MAUDE report 24571307 ↗
• InjuryJan 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED PATIENT UNDERWENT SHOULDER REVISION APPROXIMATELY 44 DAYS POST IMPLANTATION DUE TO TAPER DISASSOCIATION FROM BASEPLATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information; Pain

  MAUDE report 24179959 ↗
• InjuryDec 22, 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: Aseptic loosening; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864293 ↗
• InjuryDec 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY TWO (2) YEARS AND FIVE (5) MONTHS POST-IMPLANTATION DUE TO DISASSOCIATION OF THE TAPER AND BASEPLATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Crepitus; Insufficient Information; Pain

  MAUDE report 23791449 ↗
• 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 23610450 ↗
• InjuryNov 12, 2025Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND IMPLANT LOOSENING APPROXIMATELY FIVE (5) WEEKS AFTER AN INITIAL REVERSE SHOULDER ARTHROPLASTY PROCEDURE. A REVISION PROCEDURE WAS PERFORMED IN WHICH THE BASEPLATE, ADAPTER, POLY LINER, AND GLENOSPHERE HEAD WERE REPLACED. THE SURGICAL TECHNIQUE SPECIFIED FOR THE DEVICE WAS USED DURING THE INITIAL SURGERY. THE REVISION SURGERY WAS SUCCESSFUL, AND NO ADDITIONAL COMPLICATIONS HAVE BEEN REPORTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 23533657 ↗
• InjuryOct 28, 2025Loosening 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: Aseptic loosening; Septic loosening; Unspecified Infection

  MAUDE report 23405939 ↗
• InjuryOct 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF A REVERSE SHOULDER APPROXIMATELY THREE (3) WEEKS POST-IMPLANTATION DUE TO DISASSOCIATION OF THE TAPER ADAPTER AND BASEPLATE. DURING THE REVISION, IT WAS DISCOVERED THE BEARING WAS ALSO DISASSOCIATED FROM THE TRAY BUT THE SURGEON STATED THIS WAS A SECONDARY FAILURE AFTER THE TAPER AND BASEPLATE DISASSOCIATED AND STARTED PUTTING PRESSURE ON THE BEARING AND TRAY. IT WAS NOTED THERE IS NOT ANY KNOWN TRAUMATIC IMPACT ON THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23360825 ↗
• InjurySep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER ON AN APPROXIMATELY FOUR (4) YEARS AND SEVEN (7) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY ONE (1) YEAR AND FIVE (5) YEARS AGO DUE TO INCREASED PAIN AND LOSS OF RANGE OF MOTION DUE TO THE IMPLANT DISASSOCIATING WITH CLAVICULAR NONUNION AND SCAPULAR MALALIGNMENT.

  Patient problems: Bone Fracture(s); Bone Notching; Joint Dislocation; Loss of Range of Motion; Muscle Weakness/Atrophy; Nonunion/Delayed-union Bone Fracture; Osteolysis; Pain; Unequal Limb Length

  MAUDE report 23057752 ↗
• InjurySep 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY APPROXIMATELY SEVEN (7) YEARS AGO. THE PATIENT WAS REVISED APPROXIMATELY SIX (6) YEARS AND TEN (10) MONTHS LATER DUE TO IMPLANT DISASSOCIATION. SUBSEQUENTLY, THE PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO IMPLANT DISASSOCIATION. IT WAS NOTED THE PATIENT WAS EXPERIENCING PAIN AND ROM ISSUES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER EVENT INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Loss of Range of Motion; Pain

  MAUDE report 23031597 ↗
• InjurySep 3, 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: Insufficient Information

  MAUDE report 22954869 ↗
• InjuryAug 27, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; 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 22903763 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120121, K193373. One submission often covers many models, so check the product and lot details in each record.

• 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-1615-2020 · Feb 25, 2020 · Terminated
  Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain a
• Z-0972-2019 · Dec 21, 2018 · Terminated
  Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are indicated for use i
• Z-1208-2015 · Jan 7, 2015 · Terminated
  Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400