DELTA XTEND 130790024Recalls & reported problems

Summary

The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 10603295027836), received between Aug 31, 2017 and Sep 28, 2026 — classified as 108 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (36 reports).

10 other recalls cover devices cleared under the same FDA submission (K062250, K081620, 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 122 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50923234 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50923219 ↗
• InjurySep 17, 2026Osseointegration Problem

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 50810916 ↗
• InjurySep 17, 2026Osseointegration Problem

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 50810878 ↗
• MalfunctionMay 21, 2026Fracture

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY THE SCREW BROKE AND WAS DISCARDED. THERE WERE NO PATIENT CONSEQUENCES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244342 ↗
• 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 25056808 ↗
• 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: ON (B)(6) 2025, DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: SURGICAL INTERVENTION FOR THE REGISTRY SHOULDER: YES, DATE OF SURGICAL INTERVENTION: ON (B)(6) 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-LOCK

  Patient problems: Bone Fracture(s)

  MAUDE report 25034067 ↗
• 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: (B)(6) 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 25033928 ↗
• InjuryFeb 25, 2026Osseointegration Problem

  IT WAS REPORTED THAT FAILED GLENIOD DISTAL STEM LEFT IN PLACE. IT WAS STATED THAT BASE PLATE AND SCREWS WERE LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24443165 ↗
• 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 23935683 ↗
• 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 23818288 ↗
• 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 23558496 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL CASE IN REGARD TO (B)(4) TO CAPTURE THE PREVIOUS PARTIAL REVISION. PARTIAL REVISION; PROCEDURE: REMOVAL OF ALL COMPONENTS EXCEPT THE STEM; RETAINED COMPONENT: STEM; NEW COMPONENTS INSERTED: EPI BODY, CTA HEAD; INDICATION: SUSPECTED INFECTION; STEM WAS WELL-FIXED AND COULD NOT BE REMOVED; CTA HEAD PLACED ONTO RETAINED STEM; PURULENT FLUID OBSERVED IN BONE AND ON IMPLANTS; SWABS TAKEN FOR MICROBIOLOGICAL TESTING; PATIENT COMMENCED ON HIGH-DOSE ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 23372456 ↗
• 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 23031116 ↗
• InjuryJul 1, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENTS METAGLENE LOOSENED POST OP. METAGLENE, 2- 18 NON LOCKING SCREWS AND 2- 24MM LOCKING SCREWS BECAME LOOSE AT NON-CEMENTED INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22378619 ↗
• InjuryJul 1, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENTS METAGLENE LOOSENED POST OP. METAGLENE, 2- 18 NON-LOCKING SCREWS AND 2- 24MM LOCKING SCREWS BECAME LOOSE AT NON-CEMENTED INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI:(B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22378562 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REVERSE SHOULDER PROSTHESIS WAS IMPLANTED IN OUR HOSPITAL FOUR YEARS AGO. ITS FUNCTION IS EXCELLENT. A FIRM, ELASTIC BULGE HAS FORMED ANTERIORLY IN THE AREA OF THE DELTOIDEOPECTORAL APPROACH. RADIOLOGICAL EXAMINATION ON (B)(6) 2024, REVEALED A DISLOCATION OF THE GLENOSPHERE RELATIVE TO THE METAGLENE. THERE IS AN INDICATION FOR REPLACEMENT OF THE GLENOSPHERE AND, IF NECESSARY, ALSO THE METAGLENE IN CONJUNCTION WITH AN INLAY REPLACEMENT. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED WITH NO ISSUES NOTED.

  Patient problems: Foreign Body Reaction; Unspecified Tissue Injury

  MAUDE report 22136080 ↗
• MalfunctionMay 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE LOCKING SCREW HEADS BROKE WHEN TRYING TO ENGAGE INTO THE METAGLENE. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22103635 ↗
• InjuryJan 9, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED AS THE GLENOID IMPLANT WAS LOOSE. IT WAS AN UNKNOWN EVENT AND ALL IMPLANTS WERE REMOVED. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21114289 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTED SHOULDER. ALL IMPLANTS REMOVED AND ANTIBIOTIC SPACER PLACED. NO DELAYS IN SURGERY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 21081186 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REMOVAL OF IMPLANTS DUE TO INFECTION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. ACTIVITY LEVEL - YES. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 21072944 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS LEFT SHOULDER IS BEING REVISED DUE TO INSTABILITY. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 20752640 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS LEFT SHOULDER IS BEING REVISED DUE TO INSTABILITY. DOI: (B)(6) 2021, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 20752329 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE INFECTION. IMPLANT WAS REMOVED. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20054488 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE INFECTION. IMPLANT WAS REMOVED. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20054408 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062250, K081620, 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-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-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-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-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-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-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.
• 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-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.