DELTA XTEND 130770018Recalls & reported problems

Summary

The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 10603295027782), received between Aug 31, 2017 and Sep 17, 2026 — classified as 154 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (29 reports).

10 other recalls cover devices cleared under the same FDA submission (K062250, K120174, K192855); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 159 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Osseointegration Problem

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 50810898 ↗
• InjuryJun 10, 2026Osseointegration Problem

  IT WAS REPORTED THAT REVISION OF LEFT REVERSE TOTAL SHOULDER DUE TO LOOSE METAGLENE. ORIGINAL DOS (B)(6) 23. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25456513 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL OF ALL GLENOID IMPLANTS AND IMPLANTATION OF A CTA HEAD ONTO THE STEM DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 25059190 ↗
• InjuryMay 1, 2026Osseointegration Problem

  IT WAS REPORTED THAT PATIENT REVISED TO A HEMI CTA AFTER A FAILED REVERSE SHOULDER REVISION. PREVIOUSLY HAD AN ANATOMIC SHOULDER IN 2020. IT WAS STATED THAT METAGLENE BASEPLATE WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI - (B)(6) 2024. DOR - (B)(6) 2026. AFFECTED SIDE - RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25056773 ↗
• InjuryApr 30, 2026Fracture

  IT WAS REPORTED THAT THE METAGLEEN FAILED AND BROKE THREE SCREWS. THIS WAS THE SECOND REVISION FOR THIS PATIENT WHO ORIGINALLY HAD BONE GRAFT DONE. THE DOCTOR CONVERTED THIS TO A HEMI. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 25042932 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR DISPLACED TYPE 2B SCAPULAR SPINE FRACTURE DEVICE (RELATEDNESS): PROBABLE PROCEDURE (RELATEDNESS): CAUSAL RELATIONSHIP DATE OF EVENT: 23 FEB 2023 DATE OF IMPLANT: NO INFORMATION PROVIDED DATE OF REVISION: (B)(6) 2025 DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: SURGICAL INTERVENTION FOR THE REGISTRY SHOULDER: YES, DATE OF SURGICAL INTERVENTION: 18 MAR 2026, OPEN REDUCTION INTERNAL FIXATION (ORIF): YES, COMPONENTS REMOVED (MARK NONE OR ALL THAT APPLY.) :(* PLEASE COMPLETE A PATIENT COMPLETION/DISCONTINUATION FORMNBSP; NONE: YES . DEPUY SYNTHES PRODUCTS USED: TYPE: SCREW CATALOG NUMBER: 130960315 LOT NUMBER: RL295828 DESCRIPTION: CENTRAL METAGLENE SCREW 6MM X 15MM. TYPE: SCREW CATALOG NUMBER: 130790024 LOT NUMBER: 5547930 DESCRIPTION: DELTA XTEND LOCKING SCREW 4.5 X 24. TYPE: SCREW CATALOG NUMBER: 130770018 LOT NUMBER: 5819790 DESCRIPTION: DELTA XTEND NON-LOCKING SCREW 4.5 X 18. TYPE: SCREW CATALOG NUMBER: 130790024 LOT NUMBER: 5552950 DESCRIPTION: DELTA XTEND LOCKING SCREW 4.5 X 24. TYPE: SCREW CATALOG NUMBER: 130770018 LOT NUMBER: 5829670 DESCRIPTION: DELTA XTEND NON-LOCKING SCREW 4.5 X 18. TYPE

  Patient problems: Bone Fracture(s)

  MAUDE report 25033955 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: (B)(6) CLINICAL ADVERSE EVENT RECEIVED FOR DISPLACED TYPE 2B SCAPULAR SPINE FRACTURE DEVICE (RELATEDNESS): PROBABLE PROCEDURE (RELATEDNESS): CAUSAL RELATIONSHIP. DATE OF EVENT: (B)(6) 2023. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: SURGICAL INTERVENTION FOR THE REGISTRY SHOULDER: YES. DATE OF SURGICAL INTERVENTION: (B)(6) 2026, OPEN REDUCTION INTERNAL FIXATION (ORIF): YES. COMPONENTS REMOVED (MARK NONE OR ALL THAT APPLY.):(* PLEASE COMPLETE A PATIENT COMPLETION/DISCONTINUATION FORM.) NONE: YES . DEPUY SYNTHES PRODUCTS USED: TYPE: SCREW. CATALOG NUMBER: 130960315. LOT NUMBER: RL295828. DESCRIPTION: CENTRAL METAGLENE SCREW 6MM X 15MM. TYPE: SCREW. CATALOG NUMBER: 130790024. LOT NUMBER: 5547930. DESCRIPTION: DELTA XTEND LOCKING SCREW 4.5 X 24. TYPE: SCREW. CATALOG NUMBER: 130770018. LOT NUMBER: 5819790. DESCRIPTION: DELTA XTEND NON-LOCKING SCREW 4.5 X 18. TYPE: SCREW. CATALOG NUMBER: 130790024. LOT NUMBER: 5552950. DESCRIPTION: DELTA XTEND LOCKING SCREW 4.5 X 24. TYPE: SCREW. CATALOG NUMBER: 130770018. LOT NUMBER: 5829670. DESCRIPTION: DELTA XTEND NON-LOCKING SC

  Patient problems: Bone Fracture(s)

  MAUDE report 25033901 ↗
• MalfunctionMar 13, 2026Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE DEVICE'S STERILE PACKAGING WITH BAG WAS DESCRIBED AS HARD AND TIME-CONSUMING TO OPEN, WITH A PREFERENCE EXPRESSED FOR A PLASTIC CYLINDER SIMILAR TO TRAUMA SCREW PACKAGING. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597934 ↗
• InjuryMar 3, 2026Osseointegration Problem

  IT WAS REPORTED THAT SHOULDER REVISED FOR BASEPLATE LOOSENING DUE TO INFECTION. 48MM ANTIBIOTIC SPACER IMPLANTED.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 24494245 ↗
• InjuryMar 3, 2026Osseointegration Problem

  IT WAS REPORTED THAT SHOULDER REVISED FOR BASEPLATE LOOSENING DUE TO INFECTION. 48MM ANTIBIOTIC SPACER IMPLANTED.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 24494241 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. SURGEON REMOVED ALL COMPONENTS AND INSERTED ANTIBIOTIC SPACER. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 24307554 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. SURGEON REMOVED ALL COMPONENTS AND INSERTED ANTIBIOTIC SPACER. DOI: (B)(6) 2025. DOR: (B)(6) 2026 . AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 24307553 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REMOVAL OF A SUSPECTED INFECTED DELTA XTEND SHOULDER IMPLANT FROM THE RIGHT SHOULDER DURING AN ARTHROPLASTY PROCEDURE. GLENOID METAGLENE WAS WELL FIXED IN GLENOID. PURULENT DISCHARGE WAS OBSERVED WITHIN THE HUMERAL CANAL, AND INTRAOPERATIVE SWABS WERE COLLECTED FOR ANALYSIS. THE WOUND AND HUMERAL CANAL WERE IRRIGATED WITH BETADINE, HYDROGEN PEROXIDE AND NORMAL SALINE, AND THE A CEMENT SPACER WITH VANCOMYCIN WAS IMPLANTED. THE ORIGINAL DELTA XTEND IMPLANT HAD BEEN PLACED DUE TO FAILURE OF A PREVIOUS ORIF (NON-UNION) WITH PLATE AND SCREWS. THE GLENOID METAGLENE WAS WELL FIXED IN THE GLENOID AT THE TIME OF EXPLANT. THE PATIENT'S INFECTION IS NOT CONFIRMED YET.

  Patient problems: Insufficient Information

  MAUDE report 24223649 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FRACTURE AND JOINT INSTABILITY, NECESSITATING A REVISION PROCEDURE IN WHICH THE ORIGINAL IMPLANTS WERE REPLACED WITH A CTA HEAD FOR INCREASED STABILITY. DOI: (B)(6) 2021. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 24211304 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FRACTURE AND JOINT INSTABILITY, NECESSITATING A REVISION PROCEDURE IN WHICH THE ORIGINAL IMPLANTS WERE REPLACED WITH A CTA HEAD FOR INCREASED STABILITY. DOI: (B)(6) 2021. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 24211291 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. IT WAS STATED THAT THE METEGLENE WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS BONE TO IMPLANT INTERFACE. NO ADDITIONAL INFORMATION. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 23989672 ↗
• InjuryJan 6, 2026Osseointegration Problem

  PATIENT WAS REVISED DUE TO INFECTION. IT WAS STATED THAT THE METEGLENE WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS BONE TO IMPLANT INTERFACE. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 23976809 ↗
• InjuryJan 6, 2026Osseointegration Problem

  PATIENT WAS REVISED DUE TO INFECTION. IT WAS STATED THAT THE METEGLENE WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS BONE TO IMPLANT INTERFACE. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 23976745 ↗
• InjuryJan 6, 2026Osseointegration Problem

  PATIENT WAS REVISED DUE TO INFECTION. IT WAS STATED THAT THE METEGLENE WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS BONE TO IMPLANT INTERFACE. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 23976581 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS REVISED DUE TO PAINFUL RIGHT SHOULDER. IT WAS NOTED THE GLENOSPHERE APPEARED TO BE TILTED FROM METAGLENE. THE IMPLANTS WERE REMOVED AND REPLACED. IT WAS NOTED THERE WAS A POSSIBLE INFECTION IN THE SHOULDER AND A POSSIBLE BREAK ON THE POST AT THE BOTTOM OF GLENOSPHERE AND PIECE IN THE METAGLENE POST. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23935507 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED DUE TO INFECTION. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 23818469 ↗
• InjuryDec 16, 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 INFECTION, SO SURGEON DECIDED TO REMOVED IMPLANTS AND PUT IN A HEMI SHOULDER. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 23815132 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF REVERSE LEFT SHOULDER. REASON FOR REVISION: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23558414 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS COMPLAINING OF HUMERAL PAIN. STEM WAS FOUND TO BE IN GOOD STABLE CONDITION AS WELL AS METAGLENE. SURGEON REPLACED SCREWS, GLENOSPHERE AND PLOY TO BIGGER SIZES TO GIVE MORE STABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23488236 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO HEMIARTHROPLASTY DUE TO INSTABILITY. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23031119 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062250, K120174, K192855. One submission often covers many models, so check the product and lot details in each record.

• Z-0834-2018 · Aug 31, 2017 · Terminated
  DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with n
• Z-0833-2018 · Aug 31, 2017 · Terminated
  DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients wi
• Z-0536-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+3 STD, sterile, Depuy France; REF 130742203. The device is used as a shoulder implant.
• Z-0538-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+9 STD, sterile, Depuy France; REF 130742209. The device is used as a shoulder implant.
• Z-0533-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humerus PE Cup, Dia 38/+6 STD, sterile, Depuy France; REF 130738206. The device is used as a shoulder implant.
• Z-0537-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+6 STD, sterile, Depuy France; REF 130742206. The device is used as a shoulder implant.
• Z-0534-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+9 STD, sterile, Depuy France; REF 130738209. The device is used as a shoulder implant.
• Z-0539-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42+6R RET, sterile, Depuy France; REF 130742106. The device is used as a shoulder implant.
• Z-0532-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard humeral PE Cup Dia 38/+3 STD, sterile, Depuy France; REF 130738203. The device is used as a shoulder implant.
• Z-0535-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+6R RET, sterile, Depuy France; REF 130738106. The device is used as a shoulder implant.