DELTA XTEND 130708100Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295027102), received between Aug 18, 2017 and Sep 8, 2026 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient underwent revision of Delta Xtend for periprosthetic fracture of the humeral stem from a fall.Affected Side: Right.

  Patient problems: Bone Fracture(s)

  MAUDE report 50673399 ↗
• InjuryNov 14, 2025Fracture; Fracture

  REVISION OF MONOBLOC EPIPHYSIS (LEFT SIDE) BECAUSE OF FRACTURE. PATIENT FELL DURING THEIR INPATIENT STAY AND SUFFERED A PROSTHESIS SHAFT FRACTURE WITH AN IMPLANTED REVERSE SHOULDER PROSTHESIS ON THE LEFT, WITHOUT ANY APPARENT BONE TRAUMA.

  Patient problems: Insufficient Information

  MAUDE report 23555116 ↗
• 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 22136075 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2024, THE PATIENT WAS REVISED DUE TO INSTABILITY. UNKNOWN SURGICAL DELAY. DATE OF IMPLANT UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 20712198 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXPANSION OF PROTHESIS BECAUSE OF INFECTION. PATIENT IS STRONG SMOKER. PROCEDURE SUCCESSFULLY COMPLETED WITH NO DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18912787 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A RSA FOR A PROXIMAL HUMERAL FRACTURE ON (B)(6) 2023. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, INFECTION WAS CONFIRMED. A REMOVAL SURGERY WILL BE PERFORMED AS SOON AS A PREPARATION IS READY. DOI: (B)(6) 2023. RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 18145788 ↗
• InjuryOct 4, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO REVISION OF LOOSENING COMPONENTS. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 17869864 ↗
• InjuryApr 6, 2022Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  REVISION OF A DELTA XTEND DUE TO INFECTION AND DISLOCATION. ALL COMPONENTS WERE REMOVED AND A CEMENTED SPACER WAS IMPLANTED. 4X SCREWS WERE ALSO REMOVED. THE INFECTION IMPACTED THE SOFT TISSUES CAUSING THE THEM TO BECOME LAX AND THIS RESULTED IN A DISLOCATION. COMPONENTS WERE ALSO LOOSE AS A RESULT OF THE INFECTION. POLY WEAR OBSERVED, WHICH HAVE BEEN CAUSED BY THE DISLOCATION.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 14031982 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF DELTA XTEND REVERSE SHOULDER REPLACEMENT. PT HAD A FALL AND WAS EXPERIENCING INSTABILITY AND PAIN. X-RAY SHOWED DISPLACEMENT OF STEM. ALL IMPLANTS REMOVED FROM PT, NO IMPLANTS PLACED BACK IN. IF OTHER, DESCRIBE: REVERSE SHOULDER REPLACEMENT REVISION, DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? NO, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING?YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, FACILITY NAME OF ORIGINAL IMPLANT: (B)(6) HOSPITAL, WAS DEVICE EXPLANTED? TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: PT HAD A FALL, DISPLACED THE STEM, LEAD TO INSTABILITY AND PAIN, DID PATIENT REQUIRE REVISION SURGERY? FALSE, PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? ALL IMPLANTS HAVE BEEN REMOVED FROM PT. NO IMPLANTS WERE PUT BACK IN PLACE - GIRDLESTONE. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY:

  Patient problems: No Code Available; Pain

  MAUDE report 10237682 ↗
• MalfunctionFeb 21, 2020Loss of Osseointegration; Loss of Osseointegration

  ON (B)(6) 2010: THE PATIENT UNDERWENT A REVISION OF A NON-DEPUY TSA TO A DELTA XTEND RTSA ON HER RIGHT SHOULDER. ON (B)(6) 2011: THE PATIENT WAS SEEN IN OFFICE SECONDARY TO PAIN. THE PATIENT HAD SHOULDER ASPIRATION PERFORMED WITH NO FLUID REMOVED. THE PATIENT WAS ALSO DIAGNOSED VIA RADIOGRAPH, WITH LOOSENING AT THE BONE TO CEMENT INTERFACE. ON (B)(6) 2015: THE PATIENT WAS SEEN AGAIN SECONDARY TO PAIN. THE PATIENT AGAIN HAD ASPIRATION PERFORMED TO HER SHOULDER, WITH NO FLUID AT ALL REMOVED. THE PATIENT ALSO REVEALED THAT SHE FRACTURED HER RIGHT HUMERUS AROUND THE PROSTHESIS TWO OR THREE YEARS AGO; IT WAS TREATED NONOPERATIVELY AND APPARENTLY HEALED. THE SURGEON REPORTS THIS COULD EXPLAIN THE CHANGE IN POSITION OF HER IMPLANT AT LEASE RADIOGRAPHICALLY THAT MAY NOT MEAN IT IS LOOSE AND MAY BE THAT IT IS CHANGED BASED UPON THE FRACTURE. ON (B)(6) 2017: THE PATIENT WAS SEEN AGAIN IN THE OFFICE FOR SHOULDER ASPIRATION WITH NO FLUID REMOVED. ON (B)(6) 2017: THE PATIENT WAS SEEN FOR BLOOD WORK RESULTS. THE RESULTS CONFIRM NO INFECTION. THE SURGEON AND PATIENT AGREE TO NO REVISION AND TO FOLLOW-UP YEARLY. PMH: MULTIPLE SCLEROSIS. DOI: (B)(6) 2010 (REVISION FROM NON-DEPUY IMPLANT TO DEPUY IM

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Pain

  MAUDE report 9738474 ↗
• InjuryOct 24, 2019Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  THE REVISION WAS DONE DUE TO PATIENT COMPLAINING OF PAIN. THE HUMERAL STEM WAS CEMENTED BUT WAS LOOSE AND REMOVED BY HAND. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 30, PATIENT STATUS/OUTCOME/CONSEQUENCES: NO.

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 9234951 ↗
• InjuryJun 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN AND HAD SCAPULAR NOTCHING. SURGEON REMOVED THE 8 EPI1 CEMENTED DELTA STEM, 38+3 PE CUP AND 38 ECCENTRIC GLENOSPHERE. THE POLY SHOWED WEAR ON ONE SIDE WHERE THERE WAS SCAPULAR NOTCHING. SURGEON PUT IN A 42 ECCENTRIC GLENOSPHERE, 43+3 PE CUP AND AN 8/1 EPI LONG DELTA STEM TO BYPASS THE HUMERAL DEFECT ON THE LATERAL CORTEX. DEPUY SMARTSET GMV CEMENT WAS USED TO IMPLANT THE LONG STEM. DOI: (B)(6) 2015 DOR: MAY 14, 2019. LEFT SHOULDER.

  Patient problems: No Code Available; Pain

  MAUDE report 8662373 ↗
• MalfunctionAug 18, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION POST FALL AND LOOSENING.

  Patient problems: Bone Fracture(s); Joint Dislocation; No Code Available

  MAUDE report 6804311 ↗

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-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-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-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-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-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.