Hybrid Glenoid PT-113950Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00880304459854), received between Nov 11, 2019 and Sep 29, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (6 reports).

5 other recalls cover devices cleared under the same FDA submission (K060694, K193038); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  Patient problems: Joint Impingement

  MAUDE report 50933799 ↗
• InjuryNov 26, 2025Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Bacterial Infection; Inadequate Osseointegration; Medical device site infection; Pain

  MAUDE report 23660159 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL SHOULDER PROCEDURE AND WAS SUBSEQUENTLY REVISED AFTER A ROTATOR CUFF FAILURE DUE TO A FALL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Muscle/Tendon Damage

  MAUDE report 23468394 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INITIAL RIGHT SHOULDER ARTHROPLASTY APPROXIMATELY 9 YEARS AGO. SUBSEQUENTLY ABOUT A MONTH AGO THE PATIENT REPORTED UNUSUAL PAIN AND A DECREASE IN RANGE OF MOTION WITH REFERRAL FOR CONSULTANT AND UNKNOWN TREATMENT. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Connective Tissue Disease; Loss of Range of Motion; Pain

  MAUDE report 18954021 ↗
• InjuryDec 21, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371688 ↗
• InjuryDec 18, 2023Fracture; Fracture

  IT WAS REPORTED PATIENT WAS REVISED DUE TO ROTATOR CUFF FAILURE AND IMPLANT FRACTURE APPROXIMATELY EIGHT MONTHS POST OPERATION. THE GLENOID POST AND POLY WERE EXCHANGED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 18348093 ↗
• InjuryOct 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL LEFT SHOULDER ARTHROPLASTY APPROXIMATELY SIX (6) AND A HALF YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY FIVE (5) YEARS AGO FOR AN UNKNOWN REASON. THE PATIENT WAS REVISED FROM AND ANATOMIC SHOULDER TO A REVERSE SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 17861412 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Impingement; Loss of Range of Motion; Pain

  MAUDE report 17818723 ↗
• InjuryJan 31, 2023Unstable; Noise, Audible; Unstable; Noise, Audible

  IT WAS REPORTED A PATIENT UNDERWENT A LEFT SHOULDER REVISION APPROXIMATELY FOUR(4) YEARS POST IMPLANTATION DUE TO POSTERIOR INSTABILITY, PAIN AND NOISE. DURING THE REVISION THE LEFT SHOULDER WAS FOUND TO HAVE DEGENERATIVE JOINT DISEASE, ROTATOR CUFF ARTHROPATHY, AN IRREPARABLE ROTATOR CUFF TEAR, AND SUB LUXATION OF HUMERAL HEAD. ALL COMPONENTS, EXCEPT THE HUMERAL STEM, WERE REMOVED AND REPLACED WITH ZIMMER BIOMET PRODUCT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Arthritis; Failure of Implant; Joint Laxity; Muscle/Tendon Damage; Pain; Subluxation

  MAUDE report 16270811 ↗
• InjuryDec 8, 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 AN INITIAL RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY SEVEN (7) YEARS LATER, THE PATIENT WAS REVISED DUE TO LOOSENING OF IMPLANTS AND AN INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH AN ANTIBIOTIC CEMENT SPACER.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 15946090 ↗
• InjuryDec 5, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A TEAR OF THE ROTATOR CUFF. FURTHER, THE PATIENT HAD LOOSENING OF THE GLENOID COMPONENT AND DISLOCATION OF THE POLYETHYLENE FROM THE POST IMPLANT.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 15914633 ↗
• InjuryOct 25, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY DUE TO BONE EROSION AND INSTABILITY ON AN UNKNOWN DATE. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

  Patient problems: Erosion; Failure of Implant

  MAUDE report 15670100 ↗
• InjurySep 1, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 20 MONTHS POST IMPLANTATION AFTER A SUDDEN ONSET OF PAIN AND POP IN THE SHOULDER. DURING THE REVISION, THE SURGEON EXCISED SCAR TISSUE, SYNOVITIS, AND ADVERSE TISSUE REACTION. THE GLENOID WAS FLOATING FREE IN THE JOINT AND FRACTURED THROUGH THE METAL STEM WITHIN THE GLENOID VAULT. THE GLENOID POST, GLENOID, ADAPTER, AND HEAD WERE REVISED. THE STEM WAS RETAINED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Pain; Scar Tissue; Synovitis

  MAUDE report 15335836 ↗
• InjuryAug 29, 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 THE PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAD REVISION SURGERY APPROXIMATELY ONE (1) YEAR AND EIGHT (8) MONTHS AFTER THE INITIAL SURGERY DUE TO PAIN, LOSS OF RANGE OF MOTION, AND LOOSENING OF THE IMPLANTS.

  Patient problems: Joint Dislocation; Loss of Range of Motion; Pain

  MAUDE report 15310358 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY FOR AN UNKNOWN REASON ON AN UNKNOWN DATE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15310356 ↗
• InjuryJun 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN INITIAL TOTAL COMPREHENSIVE SHOULDER PROTHESIS. AN X-RAY TAKEN AFTER 5 YEARS OF THE INITIAL SURGERY SHOW THAT THE CENTRAL POST IS BROKEN AND SEPARATED FROM THE POLYETHYLENE GLENOID COMPONENT. THE REASON FOR WHY THE CENTRAL POST IS BROKEN OFF FROM THE POLYETHYLENE GLENOID IS UNKNOWN. IMPLANTS ARE STILL IN THE PATIENT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 14681204 ↗
• InjuryMar 2, 2022Material Erosion; Loosening of Implant Not Related to Bone-Ingrowth; Material Erosion; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERSE SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, IN AN UNKNOWN TIMEFRAME POST-IMPLANTATION, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING WITH PERIPROSTHETIC OSTEOLYSIS, WEAR OF THE POLY COMPONENT, AND METALLOSIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 13653068 ↗
• InjuryDec 27, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Inflammation

  MAUDE report 13087666 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT AN INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY WAS PERFORMED. AT THE 5-YEAR VISIT, THE PATIENT REPORTED MODERATE PAIN, INSTABILITY, IMPINGEMENT, AND LOSS OF RANGE OF MOTION. GLENOID COMPONENT MIGRATION WAS NOTED ON THE X-RAY. THE PATIENT HAS BEEN REFERRED FOR AN ORTHOPEDIC CONSULT BUT HAS NOT YET HAD ANY INTERVENTION. THE OUTCOME IS PENDING.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 11835614 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 11472670 ↗
• InjuryNov 11, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN INITIAL LEFT SHOULDER ARTHROPLASTY APPROXIMATELY A YEAR AGO. SUBSEQUENTLY A REVISION OCCURRED ABOUT 2 MONTHS AGO DUE TO A LOOSENING BASEPLATE AND BONE EROSION.

  Patient problems: Failure of Implant

  MAUDE report 9307715 ↗
• InjuryNov 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL SURGERY APPROXIMATELY A YEAR AGO. SUBSEQUENTLY, THE PATIENT HAD A REVISION ABOUT 2 MONTHS LATER DUE TO A POST OPERATIVE INFECTION AND A 2 STAGE ANTIBIOTIC SPACER PLACEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 9306923 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060694, K193038. One submission often covers many models, so check the product and lot details in each record.

• Z-1403-2025 · Mar 3, 2025 · Open, Classified
  Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
• Z-2216-2017 · Apr 26, 2017 · Terminated
  Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum seale
• 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-1658-2008 · Mar 13, 2008 · Terminated
  Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural shoulder glenoid surface for implanting a Hybrid Glenoid component. This instrume
• Z-0660-2013 · Dec 6, 0012 · Terminated
  PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented