INHANCE 5500-32-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295546733), received between Aug 14, 2023 and May 21, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. LINER AND SHELL EXCHANGED. NO OTHER COMPONENTS WERE EXCHANGED OR OF CONCERN. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 25242643 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN UNSTABLE SHOULDER. CONVERTED TO 36 AND WENT UP IN POLY SIZE. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 25104021 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 24875311 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL ADVERSE EVENTS WERE RECEIVED FOR CONJOINED TENDINITIS: DEVICE AND PROCEDURE(RELATEDNESS). DEVICE RELATED: NOT RELATED. PROCEDURE RELATED: POSSIBLE. DATE OF EVENT: 05 SEP 2025 DATE OF IMPLANT: (B)(6)2025 DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: NO INFORMATION PROVIDED. SUBJECT ID: (B)(6). STUDY NO: (B)(4). TREATMENT/IMPACT: REHABILITATION, INJECTED MEDICATION (SPECIFY: 2 ML OF 1% LIDOCAINE 2 ML OF 0.25% MARCAINE AND 2 ML OF BETAMETHASONE) AND ORAL/TOPICAL MEDICATION DEPUY SYNTHES PRODUCT USED: CATALOG NUMBER: 520000036 LOT NUMBER: 662705 COMPONENT TYPE: HUMERAL UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550011240 LOT NUMBER: 663951 COMPONENT TYPE: BASEPLATE UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550300500 LOT NUMBER: 229406 COMPONENT TYPE: SCREW UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550040600 LOT NUMBER: 206414 COMPONENT TYPE: SCREW UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550532008 LOT NUMBER: 347232 COMPONENT TYPE: GLENOSPHERE UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550000360 LOT NUMBER: 664116 COMPONENT TYPE: SHELL UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550032000 LOT NUMBER: MI1777 COMPONENT TYPE: LINER UNIQUE DEVICE

  Patient problems: Muscle/Tendon Damage

  MAUDE report 23286548 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS BEEN TREATED FOR WOUND DRAINAGE MULTIPLE TIMES. BROUGHT IN FOR I&D POSSIBLE EXCHANGE LINER. ALL IMPLANTS LOOKED INTACT. WASHED OUT AND EXCHANGED THE LINER. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE : RIGHT SHOULDER.

  Patient problems: Fluid Discharge

  MAUDE report 22560587 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD SHOULDER DONE ORIGINALLY ON (B)(6) 2024. PATIENT WAS COMPLAINING OF SOME PAIN ASSOCIATED WITH IMPINGEMENT OF THE CONJOINT TENDON. THE SURGEON FELT THE PATIENT WOULD BENEFIT FROM AN EXCHANGE OF THE GLENOSPHERE, HUMERAL SHELL, AND POLY. A 32+4 GLENOSPHERE WAS REMOVED AND REPLACED WITH A 36+4 ECCENTRIC. THE ECCENTRICITY WAS DIALED POSTERIOR. A NEW SHELL AND POLY WERE TRAILED AND THE SHOULDER WAS FOUND TO BE STABLE WITH IMPROVED RANGE OF MOTION. THE REAL SHELL AND POLY WERE OPENED AND IMPLANTED AND STABILITY WAS CONFIRMED ONCE REDUCED. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ACTIVITY LEVEL - YES. DOI: (B)(6) 2024. DOR: UNKNOWN. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22340506 ↗
• InjuryJun 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION OF SHOULDER POST OP. SURGEON CHANGED HEAD SHELL AND LINER. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22179091 ↗
• InjuryMay 29, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE SURGEON IMPLANTED A 36 MM GLENOSPHERE IN THE SHOULDER. THE SALES REP GAVE THE CIRCULATING NURSE A 32 MM INHANCE LINER IMPLANT TO OPEN ONTO THE STERILE FIELD. SALES REP MADE A MISTAKE BY GRABBING THE WRONG SIZE LINER IMPLANT TO MATCH THE GLENOSPHERE IMPLANT. A DIFFERENT SALES REP REALIZED THE MISTAKE WAS MADE AFTER THE SURGERY WAS COMPLETE WHEN HE WAS FILLING OUT THE PAPERWORK. REVISION SURGERY WAS PERFORMED LATER THAT DAY BY SURGEON TO SWITCH THE LINER TO A 36 MM IMPLANT. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 22107374 ↗
• InjuryMar 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD THEIR SHOULDER DONE BY SURGEON ON (B)(6) 2025. UNFORTUNATELY THEY DISLOCATED THEIR SHOULDER. THE SURGEON OPTED TO REVISE THE SHOULDER AND UPSIZE THE COMPONENTS TO PROVIDE STABILITY. A 32 GLENOSPHERE WAS REMOVED, AS WELL AS THE MEDIUM +0 HUMERAL SHELL AND 32 POLY. A 36+8 GLENOSPHERE WAS IMPLANTED. A TRIAL REDUCTION WAS PERFORMED WITH A 0 SHELL AND 36+0 RETENTIVE POLY. STABILITY OF THE SHOULDER WAS CONFIRMED AND THE REAL SHELL AND POLY WERE OPENED AND IMPLANTED. NO ADVERSE EVENTS OR DELAYS TOOK PLACE. ONCE NEW IMPLANTS WERE INSERTED, THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 21633174 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 21213361 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 20823103 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: A. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? -NO POLY WEAR. B. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? - NOT MALPOSITIONED. C. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? -NOT UNDERSIZED. D. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? -THIS WAS A SHOULDER ARTHROPLASTY. E. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? -NO DELAY.

  Patient problems: Joint Laxity

  MAUDE report 19816688 ↗
• InjuryMar 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR A POST OP CHECKUP WITH SOME SHOULDER SORENESS. UNFORTUNATELY HER SHOULDER HAD BECOME DISLOCATED. A CLOSED REDUCTION WAS PERFORMED AND SHE DISLOCATED AGAIN. THE SURGEON FELT THE PATIENT WOULD BENEFIT FROM A EXCHANGE OF THE GLENOSPHERE AND HUMERAL SHELL/POLY. THE 32 GLENOSPHERE WAS REMOVED AND A 36 WAS IMPLANTED. A TRIAL REDUCTION WAS PERFORMED WITH A +0 METAL SHELL AND +0 RETENTIVE POLY. STABILITY WAS CONFIRMED AND THE REAL IMPLANTS WERE OPENED AND INSERTED. THERE WERE NO SURGICAL DELAYS OR ADVERSE EVENTS TOOK PLACE. THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation; Joint Laxity; Pain

  MAUDE report 18956427 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT BROUGHT BACK FOR A WASHOUT FOR A POSSIBLE INFECTION. WHILE THERE, A 50MM METAGLEN SCREW WAS REMOVED. A NEW GLONOSPHERE , HUMERAL SHELL AND LINER WERE REPLACED. DOI: (B)(6) 2023 DOE: (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 18838133 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HER SHOULDER REPLACED APPROXIMATELY A YEAR AGO AND HAVE AN INHANCE REVERSE SHOULDER IMPLANTED. PATIENT CAME TO DOCTOR BECAUSE OF SHOULDER PAIN. AFTER TRYING OTHER NON-SURGICAL TREATMENTS THE DECISION WAS MADE TO REVISE THE SHOULDER TO FIND THE PAIN SOURCE. DURING THE REVISION PROCEDURE SCAR TISSUE WAS EXCISED, THE COMPONENTS WERE WELL FIXED, AND TEST FOR INFECTION CAME BACK NEGATIVE. THE HUMERAL TRAY AND POLY WERE EXPLANTED AND NEW COMPONENTS WERE REPLACED. DOI: APPROXIMATELY A YEAR AGO. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Adhesion(s); Pain

  MAUDE report 17540022 ↗