DELTA XTEND 130738203Recalls & reported problems

Summary

The FDA's MAUDE database contains 175 adverse event reports that list this exact device (DI 10603295027362), received between Jul 20, 2017 and Jul 30, 2026 — classified as 162 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (70 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 175 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had limited range of motion. Upon revision, the stem was found to be loose in its cement mantle. All components but the metaglene and screws were revised. It was stated that humeral stem was loose. Loosening interface was marked as cement to implant. Cement manufacturer was marked as DePuy Synthes. DOI: (b)(6) 2026.DOR: (b)(6)2026.Affected side: Right shoulder.

  Patient problems: Loss of Range of Motion

  MAUDE report 50091016 ↗
• MalfunctionJul 30, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50084096 ↗
• MalfunctionMay 13, 2026Difficult to Insert

  IT WAS REPORTED THAT 38+3 POLY WAS NOT LOCKING ONTO EPIPHYSIS IT WAS GETTING HUNG UP ANTERIORLY SWITCHED TO A 42 DOE: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

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

  MAUDE report 25159351 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DXTEND STAND PE CUP D38 +3MM WAS INVOLVED IN AN EVENT CONCERNING SCAPULAR NOTCHING FOLLOWING A REVERSE SHOULDER ARTHROPLASTY. THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE GLENOSPHERE, EPIPHYSIS, AND POLYETHYLENE CUP. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Bone Notching

  MAUDE report 24857435 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS MULTIPLE MEDICAL ISSUES. PATIENT WAS REVISED FOR INFECTION PREVIOUSLY AND THEN DISLOCATED THE REVERSE SHOULDER. THEY HAD TO GO IN AND LENGTHEN THE CONSTRUCT. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24831910 ↗
• 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 24223643 ↗
• 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 24211269 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY AND REMOVAL OF IMPLANTS FROM DELTA EXTEND OCCURRED ON (B)(6) 2026 DUE TO INFECTION. REMOVAL OF GLENNOSPHERE AND LINER WITH A WASH OUT WITH SALINE AND BACTISURE. IMPLANTED WITH NEW HARDWARE.

  Patient problems: Unspecified Infection

  MAUDE report 24119943 ↗
• 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 23818487 ↗
• InjuryDec 2, 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 PAIN. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Pain

  MAUDE report 23692455 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS RETURNED TO SURGERY TO ADDRESS JOINT TENSIONING. PATIENT INJURED SHOULDER AND SURGEON WANTED TO INCREASE POLY THICKNESS, SO A LINER EXCHANGE WAS DONE.. THERE WAS NO LOOSENING OF IMPLANTS, NO IMPLANT FAILURE OR CONCERNS. ORIGINAL POLY WAS REMOVED. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23644002 ↗
• 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 23372453 ↗
• InjuryOct 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATING SHOULDER. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 23310559 ↗
• InjuryAug 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT UNFORTUNATELY THE PATIENT DISLOCATED AGAIN. THE DOCTOR FELT THE PATIENT WOULD BENEFIT FROM A CHANGE OF THE POLY AND GLENOSPHERE. THE DOCTOR CHANGED THE 38+0 GLENOSPHERE TO A 42+6 GLENOSPHERE. THEN A 42+6 RETENTIVE POLY WAS TRIALED AND FOUND TO BE STABLE. THE REAL POLY WAS OPENED AND IMPLANTED AND STABILITY WAS CONFIRMED. NO ADDITIONAL DELAYS OR ADVERSE EVENTS TOOK PLACE. CLOSING PROCESS BEGAN.

  Patient problems: Joint Dislocation

  MAUDE report 22840793 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH THIS WEDGE BASEPLATE DUE TO INSTABILITY AND IT MAY HAVE BEEN LOOSE. THERE WAS LOOSENING OF BASEPLATE AT NON BONE TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. THE SURGEON TOOK OUT BASEPLATE IN A STD BASEPLATE WITH CENTRAL SCREW, AND PUT IN NEW GLENOSPHERE, UPSIZED POLY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22806501 ↗
• InjuryJul 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22590483 ↗
• MalfunctionJul 8, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT WAS HAVING THE DELTA REVERSE SHOULDER CONSTRUCT REVISED AFTER PATIENT HAD A FALL AND FRACTURED HER SCAPULA. THE SHOULDER WAS REVISED WITH NEW COMPONENTS. WHEN THE SURGEON WAS IMPLANTING THE 38MM + 3 POLY, THE POLY DID NOT SEAT DOWN, THERE WAS A QUESTION IF THE POLY COULD HAVE BEEN DAMAGED. THE POLY WAS REMOVED FROM THE FIELD AND A NEW POLY WAS IMPLANTED WITHOUT ANY INCIDENCE. NO ADVERSE EFFECTS TO PATIENT OR SURGICAL DELAY. DOE: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22439047 ↗
• 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 22136042 ↗
• InjuryMay 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS NO IMPLANT FAILURE; SIZED GLENO UP FOR LATERALIZATION. THERE WAS NO LOOSENING, NO SURGEON COMPLAINT, NO BROKEN IMPLANT OR INSTRUMENT, NO DELAY. NO PIECES WERE LEFT BEHIND. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22103752 ↗
• InjuryMay 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. DID A POLY SWAP. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22026668 ↗
• InjuryMar 19, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT THIS WAS A REVISION SURGERY PERFORMED ON (B)(6) 2025. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE FIRST SURGERY WITH THE PRODUCT IN QUESTION. HOWEVER, AFTER SURGERY DISLOCATION WAS CONFIRMED. THEREFORE, THE REVISION SURGERY WAS PERFORMED. THE CUP IN QUESTION WAS WORN OUT, SO THE CUP WAS REPLACED, AND THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 21641434 ↗
• InjuryMar 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO DISLOCATION - SOME OSTEOPHYTES BUT THE SURGEON COMMENTED HE SHOULD HAVE LATERALISED MORE AS PER MATERIALISE PLAN. SURGEON LATERALISED THE GLENOSPHERE AN EXTRA 2MM (ORIGINALLY 2MM AND LATERALISED TO 4MM) ALSO REPLACED +3/38MM POLY TO +6 RETENTIVE / 38MM. THERE WAS NOTHING WRONG WITH THE PRODUCTS; THE PATIENT'S ANATOMY OF THE SCAPULAR NECK WAS IMPINGING ON THE ORIGINAL GLENOSPHERE SO BY LATERALISING AND UPSIZING THE CUP, THERE WAS NO IMPINGEMENT. THE PATIENT HAD DISLOCATED 3 TIMES, WITH MUA THE FIRST TWO TIMES AND REVISION SURGERY THE THIRD TIME. THE SHOULDER WAS DISLOCATING DUE TO HAVING OSTEPHYTES PRESENT STILL AS WELL AS NOT BEING LATERAL ENOUGH, AND THE IMPLANTS WERE IMPINGING ON THE NECK OF THE HUMERUS. AFFECTED SIDE: LEFT.

  Patient problems: Joint Dislocation; Unspecified Tissue Injury

  MAUDE report 21631847 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN UNSTABLE SHOULDER. THE SURGEON UP SIZED CUP COMPONENTS. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 21458433 ↗
• InjuryFeb 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. INCREASED CUP THICKNESS. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 21312364 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SOME ANTERIOR SHOULDER PAIN, BELIEVED TO BE RELATED TO THE PATIENT'S SUBSCAP REPAIR. SURGEON SAID THE BONE SCAN SHOWED THE METAGLENE TO POTENTIALLY BE LOOSE. THE SURGEON REMOVED THE GLENOSPHERE AND SCREWS TO ASSESS THE METAGLENE. IT WAS WELL FIXED, BUT THE SURGEON FELT IT WAS BEST TO REPLACE IT BECAUSE OF THE STRESS PUT ON THE METAGLENE WHILE TESTING IT OUT. THERE WERE NO DELAYS. NO COMMENTS OR CONCERNS WERE EXPRESSED ABOUT THE QUALITY OF PRODUCTS. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 21306996 ↗

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-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-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-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-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.
• 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.