DELTA XTEND 130790048Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295027874), received between Sep 6, 2017 and Nov 14, 2025 — classified as 24 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 30 reports, in the reporter's own words as published by the FDA.

• 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 23558399 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR SUSPICION OF PROSTHETIC INFECTION - LEFT SHOULDER. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE OR PROCEDURE. DATE OF IMPLANT: (B)(6) 2024. DATE OF EVENT: (B)(6) 2024. (LEFT SHOULDER). TREATMENT: I&D. NO REVISION COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 19562921 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING WAS EXPLANTED AND A SPACED WAS PUT IN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19384334 ↗
• InjuryApr 29, 2024Adverse 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 INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE OR PROCEDURE. DATE OF IMPLANT: (B)(6) 2024, DATE OF EVENT: (B)(6) 2024. (RIGHT SHOULDER). TREATMENT: INJECTED MEDICATION.

  Patient problems: Unspecified Infection

  MAUDE report 19203109 ↗
• InjuryApr 26, 2024Adverse 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 PERIPROSTHETIC INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE OR PROCEDURE. DATE OF IMPLANT: (B)(6) 2023, DATE OF EVENT: (B)(6) 2024, (RIGHT SHOULDER). TREATMENT: I&D AND INJECTED MEDICATION.

  Patient problems: Unspecified Infection

  MAUDE report 19193438 ↗
• MalfunctionJan 18, 2023Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED. A. WAS THERE ANY ADVERSE CONSEQUENCE TO THE PATIENT RELEVANT TO THIS EVENT? IF YES, PLEASE KINDLY PROVIDE DETAILS. -HAS BROKEN PART OF SCREW STILL IN GLENOID BUT NO ADVERSE CONSEQUENCE AT THE TIME OF REPORTING OTHER THAN IT BEING THERE, B. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? -NO.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195507 ↗
• InjuryApr 13, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT PREVIOUSLY HAD SHOULDER ARTHROPLASTY REVISION SURGERY FROM ANATOMIC TO REVERSE ON (B)(6) 2018. THEY USED A BIO RSA BONE GRAFT ON THE GLENOID SIDE DUE TO GLENOID BONE LOSS. THIS BONE GRAFT RESORBED AND SUBSEQUENTLY THE GLENOID FIXATION FAILED AND THE GLENOID COMPONENTS BECAME LOOSE. THIS RESULTED IN DISLOCATION. THE IMPLANTS HAVE ALL BE EXPLANTED AND SHOULDER FUSION PROCEDURE CARRIED OUT. THERE WERE SCREWS IN THE METAGLENE ALSO, HOWEVER I WAS UNABLE TO OBTAIN THE LOT NUMBERS AS THEY WERE UNREADABLE DOI: (B)(6) 2018, DOR: (B)(6) 2022, UNKNOWN SHOULDER.

  Patient problems: Inadequate Osseointegration; Inflammation

  MAUDE report 14102109 ↗
• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. REVISION FOR INFECTION - WAS THERE ANY SUGGESTION BY ANYONE INDICATING THAT THERE WAS OR MAY BE DEFICIENCY WITH THE PRODUCT(S)? IF YES, PLEASE PROVIDE DETAILS. THE SURGEON DID NOT NOTE ANY DEFICIENCY WITH THE IMPLANTS CAUSING THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 12843878 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A DELTA XTEND DUE TO INFECTION, LOOSENING, AND PERIPROSTHETIC FRACTURE (WHICH APPEARED TO HAVE HEALED). UPON EXPOSURE IT WAS VERY CLEAR THAT THE INFECTION WAS WIDESPREAD AND WAS AFFECTING ALL COMPONENTS. ALL COMPONENTS WERE REMOVED AND A CEMENT SPACER WAS IMPLANTED WHILE THE INFECTION CLEARS. PRIMARY SURGERY WAS DONE ON (B)(6) 2016. FEMALE, RIGHT SIDE. PRIOR TO THIS THE PATIENT HAD A PROXIMAL HUMERAL FRACTURE. I CAN'T RECALL THE EXACT DATE. THIS WAS ADDRESSED USING A PROXIMAL HUMERAL PLATE WHICH SUBSEQUENTLY FAILED LEADING TO THE DELTA XTEND IN 2016. THE PATIENT HAD FRACTURED JUST DISTAL TO THE HUMERAL STEM, BUT BY THE TIME THE REVISION WAS BOOKED IT APPEARED TO HAVE HEALED. STEM WAS LOOSE. LOOSENING WAS MOSTLY ATTRIBUTED TO INFECTION. THE PERIPROSTHETIC FRACTURE WAS TALKED ABOUT BEING A CONTRIBUTING FACTOR TO LOOSENING. ALL COMPONENTS WERE REMOVED AND A SPACER WAS CEMENTED IN.

  Patient problems: Unspecified Infection

  MAUDE report 12740735 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A DELTA XTEND DUE TO INFECTION, LOOSENING, AND PERIPROSTHETIC FRACTURE (WHICH APPEARED TO HAVE HEALED). UPON EXPOSURE IT WAS VERY CLEAR THAT THE INFECTION WAS WIDESPREAD AND WAS AFFECTING ALL COMPONENTS. ALL COMPONENTS WERE REMOVED AND A CEMENT SPACER WAS IMPLANTED WHILE THE INFECTION CLEARS. PRIMARY SURGERY WAS DONE ON (B)(6) 2016. FEMALE, RIGHT SIDE. PRIOR TO THIS THE PATIENT HAD A PROXIMAL HUMERAL FRACTURE. I CAN'T RECALL THE EXACT DATE. THIS WAS ADDRESSED USING A PROXIMAL HUMERAL PLATE WHICH SUBSEQUENTLY FAILED LEADING TO THE DELTA XTEND IN 2016. THE PATIENT HAD FRACTURED JUST DISTAL TO THE HUMERAL STEM, BUT BY THE TIME THE REVISION WAS BOOKED IT APPEARED TO HAVE HEALED. STEM WAS LOOSE. LOOSENING WAS MOSTLY ATTRIBUTED TO INFECTION. THE PERIPROSTHETIC FRACTURE WAS TALKED ABOUT BEING A CONTRIBUTING FACTOR TO LOOSENING. ALL COMPONENTS WERE REMOVED AND A SPACER WAS CEMENTED IN.

  Patient problems: Unspecified Infection

  MAUDE report 12740711 ↗
• InjuryJul 12, 2021Off-Label Use; Osseointegration Problem; Off-Label Use; Osseointegration Problem

  NO INSTRUMENTATION BROKE. SURGEON PURPOSELY USED A RIGHT IN A LEFT SHOULDER DUE O UNIQUE ANATOMY. IT WAS ASSUMING LOOSENING WAS CAUSED BY INFECTION.

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

  MAUDE report 12152746 ↗
• InjuryMar 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF DELTA XTEND DUE TO INFECTION. PROSTHESIS REMOVED AND SPACER USED.

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

  MAUDE report 11574972 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL PRIMARY OPERATION WAS IN (B)(6) 2013. PATIENT BECAME UNWELL AND THERE WAS A SUSPICION OF INFECTION. THE SHOULDER HAD PREVIOUS WASHOUTS WITH NO REAL BENEFIT. ALL IMPLANTS WERE REMOVED AND A TEMPORARY CEMENTED SPACER WAS IMPLANTED.

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

  MAUDE report 11486262 ↗
• InjuryJan 27, 2021Osseointegration Problem; Osseointegration Problem

  REVISION OF SHOULDER PROSTHESIS RIGHT SIDE AS PATIENT SUFFERED TWO FALLS BEFORE. THERE WAS LOOSENING AT THE BONE TO IMPLANT INTERFACE. DOI: UNKNOWN, DOR: (B)(6) 2020; RIGHT SHOULDER.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 11239505 ↗
• InjuryDec 15, 2020Fracture; Fracture

  REVISION RIGHT DELTA XTEND TSR. PATIENT UNDERWENT PRIMARY SURGERY IN 2012 AT ANOTHER FACILITY AND DIFFERENT SURGEON. PRESENTED TO CURRENT SURGEON COMPLAINING OF PAIN. SURGEON SUSPECTED CAUSE AS SCAPULAR NOTCHING. SURGERY UNDERTAKEN TO REMOVE POLY INSERT, GLENOSPHERE AND BROKEN INFERIOR METAGLENE SCREW. BROKEN PORTION OF SCREW UNABLE TO BE REMOVED AND LEFT IN-SITU. PREVIOUS 38 ECC GLENOSPHERE REMOVED AND A 42 ECC INSERTED. TRAIL REDUCTION WITH 42, + 6 STD POLY INSERT. SURGEON SATISFIED WITH RANGE OF MOTION, DEFINITIVE 42, + 6 STD POLY IMPACTED AND SHOULDER REDUCED.

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

  MAUDE report 11006434 ↗
• MalfunctionSep 1, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE LEFT SHOULDER. THE EXACT ORIGINAL IMPLANT DATE WAS (B)(6) 2020. LOCKING SCREWS WERE USED AND THERE'S NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10478648 ↗
• MalfunctionSep 1, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE LEFT SHOULDER. THE EXACT ORIGINAL IMPLANT DATE WAS (B)(6) 2020. LOCKING SCREWS WERE USED AND THERE'S NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10478640 ↗
• MalfunctionJul 25, 2020Fracture; Fracture

  IT WAS REPORTED THAT ONE OF THE TOP FLUTES OF THE METAGLENE SCREW BROKE OFF WHILE THE SURGEON WAS TURNING THE SCREW. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10324193 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFFECTED SIDE IS THE LEFT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10130059 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFFECTED SIDE IS THE LEFT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10130042 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REASON FOR REVISION: PAIN DUE TO POSSIBLE INFECTION THE SURGEON HAD PRIOR CONCERNS WITH REGARDS THE PATIENTS SKIN CONDITION (LETTER AVAILABLE). THE PATIENT HAS SUBSEQUENT TO PRIMARY SURGERY PRESENTED WITH PAIN IN THE SHOULDER. THE SURGEON HAS TREATED THE PATIENT CONSERVATIVELY TO ADDRESS POSSIBLE INFECTION. CONSERVATIVE TREATMENT HAS NOT ADDRESSED THE PROBLEM AND THE SURGEON HAS TAKEN THE DECISION TO CARRY OUT A TWO STAGE REVISION, REMOVE ALL COMPONENTS AND TEMPORARILY REPLACE WITH A CEMENT SPACER. SURGEON WILL ADVISE ON WHEN THE PATIENT WILL BE BROUGHT BACK FOR SURGERY.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 9910508 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LACK OF ROM. DOI: (B)(6) 2019. DOR: (B)(6) 2020, LEFT SHOULDER.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9764062 ↗
• InjuryNov 26, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE METAGLENE AT THE BONE TO IMPLANT INTERFACE. A FAILED GLENOID REVISION RECONSTRUCTION CONVERTED TO DELTA CTA. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9377577 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE HUSBAND OF THE PATIENT THOUGHT THE INFECTION WAS CAUSED BY THE IMPLANT. DOI: (B)(6) 2019; DOI: (B)(6) 2019 (PE CUP); DOR: (B)(6) 2019, RIGHT SHOULDER.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8910567 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2019. RIGHT SHOULDER.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8815967 ↗

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-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-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-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-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-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-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.