INHANCE 5500-35-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295548805), received between Jul 11, 2023 and Sep 15, 2026 — classified as 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revision due to infection/fracture from fall.DOI: (b)(6) 2025.DOR: (b)(6) 2026.Affected Side: Right.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 50771532 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that all Inhance reverse implants were explanted due to infection.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected Side: Unknown Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50751271 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED THE PATIENT EXPERIENCED PERSISTENT INSTABILITY IN THE LEFT SHOULDER FOLLOWING A REVERSE TOTAL SHOULDER ARTHROPLASTY, DESPITE INITIAL POSTOPERATIVE IMPROVEMENT. IMAGING CONFIRMED STABLE ALIGNMENT OF THE IMPLANT, AND THE INSTABILITY DID NOT RESULT IN A TRUE GLENOHUMERAL DISLOCATION. PERSISTENT SYMPTOMS LED TO A DIAGNOSTIC CT SCAN TO ASSESS PROSTHESIS STABILITY AND POSITION. DEVICE RELATED: POSSIBLE (HUMERAL STEMLESS IMPLANT: YES); PROCEDURE RELATED: POSSIBLE; DATE OF EVENT: (B)(6) 2026; DATE OF IMPLANT: (B)(6) 2025; DATE OF REVISION: NO INFORMATION PROVIDED; DEVICE LOCATION: LEFT. TREATMENT/IMPACT: DIAGNOSTIC INTERVENTION (CT). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 520000036; LOT NUMBER: 662988; COMPONENT TYPE: HUMERAL; DESCRIPTION: INHANCE SHOULDER SYSTEM STEMLESS MEDIUM DIAMETER 36MM CEMENTLESS. CATALOG NUMBER: 550011240; LOT NUMBER: 664496; COMPONENT TYPE: BASEPLATE; DESCRIPTION: INHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE SMALL Ø24MM; CEMENTLESS. CATALOG NUMBER: 550035600; LOT NUMBER: 206439; COMPONENT TYPE: SCREW; DESCRIPTION: INHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 35MM. CATALOG NUMBE

  Patient problems: Joint Laxity; Pain

  MAUDE report 24616175 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR JOINT EFFUSION (POSSIBLE INFECTION OF RIGHT SHOULDER INCISION. PT CALLED OFFICE ON (B)(6) STATES HE WAS ADMITTED TO HOSPITAL IN (B)(6) ON (B)(6) ON IV ANTIBIOTICS). NO RELATIONSHIP TO STUDY DEVICE: NOT RELATED. RELATIONSHIP TO PRIMARY STUDY PROCEDURE: POSSIBLE. DATE OF EVENT: 29 DEC 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: HOSPITALIZATIONS, DIAGNOSTIC INTERVENTIONS (VNOUS DUPLEX, ULTRASOUND, MRI, XRAY), INJECTED MEDICATIONS (VANCOMYCIN IVPB 2000MG, PIPERACILLIN-TAZOBACTAM IV 4.5MG), ASPIRATIONS, ORAL/TOPICAL MEDICATION (LIDOCAINE 5% PATCH, ACETAMINOPHEN-CODEINE 300-30MG, PO LINEZOLID 600 BID AND AUGMENTIN 875 BID X 1 WEEK), DEBRIDEMENT, ANTIBIOTICS, IMPLANT RETENTION DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550536008, LOT NUMBER: 354222, COMPONENT TYPE: GLENOSPHERE, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550035600, LOT NUMBER: 233591, COMPONENT TYPE: SCREW, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550300500, LOT NUMBER: 235422, COMPONENT TYPE: SCREW, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550011240, LOT NUMBER: 664506,

  Patient problems: Unspecified Infection

  MAUDE report 24389882 ↗
• MalfunctionFeb 11, 2026Migration

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR IMPLANT SHIFT DEVICE RELATED: CASUAL RELATIONSHIP (HUMERAL STEMLESS IMPLANT: YES) PROCEDURE RELATED: POSSIBLE DATE OF EVENT: 26 JAN 2026 DATE OF IMPLANT: (B)(6) 2025 DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: OBSERVATION DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550011240 LOT NUMBER: 66451 COMPONENT TYPE: BASEPLATE DESCRIPTION: ENHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE SMALL Ø24MM CEMENTLESS. CATALOG NUMBER: 550035600 LOT NUMBER: 237381 COMPONENT TYPE: SCREW. DESCRIPTION: ENHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 35MM. CATALOG NUMBER: 550310035 LOT NUMBER: 229426 COMPONENT TYPE: SCREW. DESCRIPTION: ENHANCE SHOULDER SYSTEM LOCKING SCREW 35MM. CATALOG NUMBER: 550310025 LOT NUMBER: 233600 COMPONENT TYPE: SCREW DESCRIPTION: ENHANCE SHOULDER SYSTEM LOCKING SCREW 25MM. CATALOG NUMBER: 550310035 LOT NUMBER: 223956 COMPONENT TYPE: SCREW DESCRIPTION: ENHANCE SHOULDER SYSTEM LOCKING SCREW 35MM. CATALOG NUMBER: 550540008 LOT NUMBER: 333136 COMPONENT TYPE: GLENOSPHERE DESCRIPTION: ENHANCE SHOULDER SYSTEM GLENOSPHERE Ø40+8MM. CATALOG NUMBER: 520000044 LOT NUMB

  Patient problems: Insufficient Information

  MAUDE report 24313100 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR POSSIBLE INFECTION OF RIGHT SHOULDER INCISION. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NOT RELATED. PROCEDURE RELATED: POSSIBLE. DATE OF EVENT: 29 DEC 2025. DATE OF IMPLANT: (B)(6) 2025 DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: HOSPITALIZATION, DIAGNOSTIC INTERVENTION (VENOUS DUPLEX, ULTRASOUND, MRI, XRAY), INJECTED MEDICATION (VANCOMYCIN IVPB 2000MG, PIPERACILLIN-TAZOBACTAM IV 4.5MG), ORAL/TOPICAL MEDICATION (LIDOCAINE 5% PATCH, ACETAMINOPHEN-CODEINE 300-30MG, PO LINEZOLID 600 BID AND AUGMENTIN 875 BID X 1 WEEK).

  Patient problems: Unspecified Infection

  MAUDE report 24073118 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR POSSIBLE INFECTION OF LEFT SHOULDER INCISION. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NOT RELATED. PROCEDURE RELATED: POSSIBLE. DATE OF EVENT: 29 DEC 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: HOSPITALIZATION, INJECTED MEDICATION (PT STATES HE IS ON IV ANTIBIOTICS).

  Patient problems: Unspecified Infection

  MAUDE report 24071817 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE SUBLUXATION EVENT DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NOT RELATED PROCEDURE RELATED: PROBABLE. DATE OF EVENT: 20 DEC 2025, DATE OF IMPLANT: (B)(6) 2025, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: OTHER NON-SURGICAL TREATMENTS: YES (SPECIFY: HOLD FORMAL PT AND RESUME USING THE SHOULDER IMMOBILIZER FOR THE NEXT 3 WEEKS. HE CAN DO PENDULUM EXERCISES BUT WILL HOLD ON TO THE REMAINDER OF HIS HOME EXERCISE PROGRAM. IN THREE WEEKS, HE CAN WEAN FROM THE IMMOBILIZER AGAIN AND RESUME OUTPATIENT PT.)

  Patient problems: Joint Laxity

  MAUDE report 24042740 ↗
• InjuryDec 26, 2025Osseointegration Problem; Osseointegration Problem

  SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR SHOULDER REVISION. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: NO INFORMATION PROVIDED. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: WERE DEPUY SYNTHES COMPONENTS REMOVED: YES. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: WERE DEPUY SYNTHES COMPONENTS REMOVED: YES (CUP, METAGLENE, HEAD/GLENOSPHERE); INHANCE REVERSE SHOULDER ARTHROPLASTY WAS REVISED AND CONVERTED TO AN INHANCE HEMIARTHROPLASTY, FOR TREATMENT OF ASEPTIC LOOSENING OF THE INHANCE BASEPLATE AND SCREWS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23896034 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR WORSENING BILATERAL SHOULDER PAIN DEVICE RELATED: NOT RELATED. PROCEDURE RELATED: POSSIBLE. DATE OF EVENT: 19 NOV 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REHABILITATION, INJECTED MEDICATION (TRIAMCINOLONE (KENALOG-40) INJECTION 20-120 MG) DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 520000040. LOT NUMBER: 662039. COMPONENT TYPE: HUMERAL. DESCRIPTION: INHANCE SHOULDER SYSTEM STEMLESS LARGE DIAMETER 40MM CEMENTLESS. CATALOG NUMBER: 550011240. LOT NUMBER: 663949. COMPONENT TYPE: BASEPLATE. DESCRIPTION: INHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE SMALL Ø24MM CEMENTLESS. CATALOG NUMBER: 550300500. LOT NUMBER: 220085. COMPONENT TYPE: SCREW. DESCRIPTION: INHANCE SHOULDER SYSTEM SELF-DRILLING & LOCKING SCREW 4 PACK 20MM & 25MM. CATALOG NUMBER: 550035600. LOT NUMBER: 217704. COMPONENT TYPE: SCREW. DESCRIPTION: INHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 35MM. CATALOG NUMBER: 550532008. LOT NUMBER: 345531. COMPONENT TYPE: GLENOSPHERE. DESCRIPTION: INHANCE SHOULDER SYSTEM GLENOSPHERE Ø32+8MM. CATALOG NUMBER: 550000400. LOT NUM

  Patient problems: Pain

  MAUDE report 23768698 ↗
• InjuryJun 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY BACK IN (B)(6) 2023 BY A DIFFERENT SURGEON. THE PATIENT EXPERIENCED PAIN AND IT WAS NOTICED THAT HIS CENTRAL SCREW BROKE AND THEREFORE NEEDED TO HAVE A REVISION SURGERY. THE SURGEON REMOVED THE REVERSE SHELL AND POLY TO GAIN EXPOSURE TO THE GLENOID. THE GLENOSPHERE WAS REMOVED, PERIPHERAL SCREWS WERE REMOVED AND THE PROXIMAL PORTION OF THE CENTRAL SCREW WAS REMOVED HOWEVER, THE BROKEN END OF THE SCREW WAS RETAINED. THE SURGEON THEN REDRILLED AND REAMED THE GLENOID FOR A NEW IMPLANT AND WITH LESS SUPERIOR TILT. A NEW BASEPLATE WAS UTILIZED A NEW CENTRAL SCREW AS WELL, AND PERIPHERAL SCREWS. THE SURGEON CHOSE TO GO UP ON GLENOSPHERE SIZE TO A 36+4, A NEW LG +0 SHELL WAS IMPLANTED WITH A NEW POLY AS WELL. THERE WAS NO ALLEGATION THAT THE PRODUCT WAS DEFECTIVE. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 22140559 ↗
• MalfunctionMar 11, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON COULD NOT ADVANCE THE 35MM CENTRAL SCREW INTO THE LARGE PLATFORM BASEPLATE. THE SCREW WOULD NOT ADVANCE PAST THE FACE OF THE BASEPLATE AFTER SEVERAL ATTEMPTS AND RE-DRILLING. FINALLY, A 7X15MM CENTRAL POST WAS PLACED INSTEAD OF THE CENTRAL SCREW. THE CENTRAL POST WAS ABLE TO BE FULLY SEATED. ONLY ONE CENTRAL SCREW WAS SCARRED UP JUST BELOW THE HEAD, THE ORIGINAL 35MM. THE SCARRING WAS DUE TO THE SCREW SOMEHOW INTERFERING WITH THE INNER BOSS OF THE BASEPLATE. THE SCREW WAS CLEAN OUT OF THE BOX. THERE WAS APPROXIMATELY 10 MINUTES OF SURGICAL DELAY TO DETERMINE THE COURSE OF ACTION AND EXECUTE IT WHICH WAS TO SWITCH TO A CENTRAL POST IMPLANT. THERE WAS NO PATIENT HARM. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21579589 ↗
• MalfunctionMar 11, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON COULD NOT ADVANCE THE 35MM CENTRAL SCREW INTO THE LARGE PLATFORM BASEPLATE. THE SCREW WOULD NOT ADVANCE PAST THE FACE OF THE BASEPLATE AFTER SEVERAL ATTEMPTS AND RE-DRILLING. FINALLY, A 7X15MM CENTRAL POST WAS PLACED INSTEAD OF THE CENTRAL SCREW. THE CENTRAL POST WAS ABLE TO BE FULLY SEATED. ONLY ONE CENTRAL SCREW WAS SCARRED UP JUST BELOW THE HEAD, THE ORIGINAL 35MM. THE SCARRING WAS DUE TO THE SCREW SOMEHOW INTERFERING WITH THE INNER BOSS OF THE BASEPLATE. THE SCREW WAS CLEAN OUT OF THE BOX. THERE WAS APPROXIMATELY 10 MINUTES OF SURGICAL DELAY TO DETERMINE THE COURSE OF ACTION AND EXECUTE IT WHICH WAS TO SWITCH TO A CENTRAL POST IMPLANT. THERE WAS NO PATIENT HARM. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21578118 ↗
• MalfunctionJun 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE INHANCE CENTRAL SCREW 6.0 X 35MM BROKE WHILE IMPLANTING INSIDE OF THE PATIENT¿S GLENOID WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, ACTION TAKEN WHEN EVENT OCCURRED? --> BASEPLATE WAS REPOSITIONED TO AVOID BROKEN SCREW AND A SHORTER SCREW WAS SELECTED, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> NO, IF NO, EXPLAIN: --> THE BROKEN SCREW WAS TOO DEEP TO REMOVE WITHOUT SEVERELY DAMAGING THE GLENOID ,

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457953 ↗
• InjuryJul 14, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO GLENOID COMPONENT LOOSENING. SURGEON STATES IT WAS DUE TO POOR BONE QUALITY. ENTIRE CONSTRUCT WAS REMOVED AND DELTA XTEND W/ CTA HEAD WAS PUT INTO PLACE DUE TO POOR BONE QUALITY. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Inadequate Osseointegration; Unspecified Tissue Injury

  MAUDE report 17324520 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON WAS SUSPICION OF INFECTION. IT IS UNKNOWN IF INFECTION WAS PRESENT. IMPLANTS WERE REMOVED. IT WAS THEN WASHED OUT AND NEW IMPLANTS WERE INSERTED. DOI: (B)(6) 2023. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17297781 ↗