DELTA XTEND 130770030Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295027805), received between Jun 17, 2019 and May 1, 2026 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 25056743 ↗
• MalfunctionJul 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT INTRAOPERATIVELY A NON-LOCKING SCREW FRACTURED DURING SCREWING INTO THE METAGLENE. IT WAS NOT POSSIBLE TO REMOVE THE FRAGMENT; REMOVING IT WOULD HAVE CAUSED TOO MUCH HARM. ANOTHER HOLE WAS USED TO INSERT ANOTHER SCREW.

  Patient problems: Foreign Body In Patient

  MAUDE report 19749242 ↗
• InjuryMay 15, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY DONE (B)(6) 2022 AT HOSPITAL. UNFORTUNATELY THE BASEPLATE AND GLENOSPHERE COMPONENTS BECAME LOOSE. THE HUMERAL COMPONENTS WERE FOUND TO BE WELL FIXED AND STABLE. SURGEON FELT THE PATIENT WOULD BENEFIT FROM A THOROUGH WASHOUT OF THEIR SHOULDER AND A REVISION OF THEIR GLENOID COMPONENTS. ONCE IMPLANTS WERE REMOVED AND THE SHOULDER WAS WASHED, THE GLENOID WAS PREPPED FOR AN INHANCE BASEPLATE. A TRIAL REDUCTION WAS PERFORMED WITH A 40 +8 ECCENTRIC GLENOSPHERE AND A 42 +6R POLY ON THE DELTA HUMERAL SIDE. SURGEON WAS OK WITH THE MISMATCH OF GLENOSPHERE TO POLY DUE TO NOT WANTING TO REVISE THE WELL FIXED HUMERAL COMPONENT. THE SHOULDER WAS FOUND TO BE STABLE, SO FINAL IMPLANTS WERE OPENED AND INSERTED. STABILITY WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. THERE WAS NO ADVERSE EVENTS OR DELAYS TOOK PLACE. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19319439 ↗
• InjuryOct 13, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE LOOSE XTEND METAGLENE REVISE TO AUGMENT METAGLENE VS CTA. POLY SWAP AND NEW GLENOSPHERE. NO OTHER INFORMATION KNOWN. DOI: UNKNOWN DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17931036 ↗
• MalfunctionMar 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT ONE OF THE NON LOCKING SCREWS¿ HEAD BROKE OFF WHILE SCREWING ONTO THE METAGLENE. THE SCREW WAS STILL PROGRESSING WHILE THE HEAD OF THE SCREW JUST TWISTED OFF. THE SCREW WAS LEFT IN THE PATIENT AND THE HEAD OF THE SCREW I WILL SEND BACK. THERE WAS NO DAMAGE TO THE PATIENT, ANY ADDITIONAL BLOOD LOSS OR TIME ADDED TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16626864 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON HAD IMPLANTED THE METAGLENE WITH SCREWS. HE MENTIONED THAT THE PATIENT BONE WAS VERY SOFT AND SCREWS WERE NOT GETTING GREAT PURCHASE. WHILE IMPLANTING THE GLENOSPHERE, HE WAS HAVING TROUBLE GETTING IT TO ENGAGE IN THE METAGLENE. WHEN HE REMOVED THE GLENOSPHERE AND NOTICED THE METAGLENE WAS TOGGLING. HE REMOVED THE METAGLENE AND THE GLENOID WAS FRACTURED. HE DECIDED TO CONVERT TO A HEMI ARTHROPLASTY. SINCE THEY DID NOT HAVE INSTRUMENTS IN THE HOSPITAL, HE USED ANOTHER COMPANY THAT HAD INSTRUMENTS STERILE ON THE SHELF. DOE: (B)(6) 2022, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 14073253 ↗
• InjuryAug 18, 2021Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE METAGLENE COMPONENT AT THE BONE TO IMPLANT INTERFACE. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2021. RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12338726 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. REMOVED ALL HARDWARE. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2021; LEFT SHOULDER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11521421 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2018; DOR: (B)(6) 2020; RIGHT SHOULDER.

  Patient problems: No Code Available

  MAUDE report 10236737 ↗
• InjuryJun 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. ALL PARTS WERE REMOVED TO TREAT THE INFECTION WITH A SPACER. DOI: (B)(6) 2019. DOR: (B)(6) 2019, RIGHT SHOULDER.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8726860 ↗
• InjuryJun 17, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS FALL AND LOOSENING OF THE METAGLENE AT CEMENT TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT PATIENT LIKELY BROKE 2 SCREWS FROM THE FALL. SURGEON DECIDED TO REVISE PATIENT SHOULDER AND REMOVED THE GLENOSPHERES, THE METAGLENE BASE PLATE, 4 SCREWS, AND THE HUMERAL CUP. THE GLENOID WAS FILLED WITH BONE GRAFT AND A DELTA CTA HEAD WAS IMPLANTED ONTO STEM. DOI: (B)(6) 2012; DOR: (B)(6) 2019, LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8703674 ↗

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-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-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-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-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.
• 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.