DELTA XTEND 130710100Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295027133), received between Feb 23, 2018 and Jul 10, 2026 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (9 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR LOOSENING AND INFECTION. IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO HUMERAL STEM LOOSENING AT BONE TO CEMENT INTERFACE. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 25778287 ↗
• InjuryMar 25, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE CEMENTED STEM CAME LOOSE. DOCTOR REPLACED IT THE WITH A STRYKER STEM. LOOSENING INTERFACE WAS MARKED AS CEMENT TO IMPLANT. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 24691424 ↗
• 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 24223646 ↗
• InjuryMay 9, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE HUMERAL STEM AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT BROKE HER HUMERUS MID SHAFT, JUST DISTAL TO THE HUMERAL STEM. SURGEON REMOVED IMPLANTS TO REVISE SHOULDER USING ANOTHER VENDOR AFTER FIXING FRACTURE. NO KNOWN INFECTION PRESENT. NO DELAY IN SURGERY. STEM WAS A LITTLE LOOSE. GLENOSPHERE WAS NOT ENGAGED VIA THE CENTRAL SCREW TO METAGLENE. METAGLENE WAS NOT LOOSE BUT REMOVED ANYWAYS. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 21996453 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EVERYTHING WAS EXPLANTED AND SPACER PUT IN. DOI :(B)(6) 2022. DOR: (B)(6),2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19953056 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REASON FOR PRIMARY SURGERY FRACTURED HUMERUS. REVISION OF DELTA DUE TO INFECTION SITE LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 18895672 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ON (B)(6) 2021, RADIOGRAPH SHOWS RIGHT SHOULDER HAS LUXATED AGAIN. ON *(B)(6) 2021, REVISION OF RIGHT SHOULDER TEP. THE DELTA EXTEND MODEL IS REMOVED AND ANOTHER TEP FORM EXACTECH, EQUINOX REVERSE MODEL WAS USED. THE SHAFT WAS NOT REPLACED. DOI: (B)(6) 2021; DOR: (B)(6) 2021; RIGHT SHOULDER.

  Patient problems: Loss of Range of Motion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16942348 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN UNKNOWN OFFICE SEEKED FOR ASSISTANCE AT JOHNSON AND JOHNSON MEDICAL DEVICES EMEA. THEY WROTE: "DEAR SIR OR MADAM, OUR CLIENT HAS BEEN UNABLE TO MOVE HER RIGHT ARM SINCE THE IMPLANTATION OF A SHOULDER TEP. IN THE MEANTIME, SHE HAS ALREADY HAD SEVERAL REVISIONS PERFORMED ON THE RIGHT SIDE, ALL OF WHICH WERE OF NO AVAIL. THE TEP CONTINUES TO DISLOCATE. MOST RECENTLY, SHE WAS IMPLANTED WITH THE PROSTHESIS FROM THE COMPANY EXACTECH, MODEL EQUINOX REVERSE. THE STEM IS STILL FROM THE COMPANY DELTA X-TEND. AS THE MANUFACTURER, CAN YOU IDENTIFY AND NAME THE RECURRENT DISLOCATION PROBLEM? IS IT POSSIBLE THAT THE TWO COMPONENTS DO NOT HARMONIZE WITH EACH OTHER? CAN YOU NAME SEVERAL DOCTORS IN GERMANY WHO REGULARLY WORK WITH THESE PROSTHESES AND COULD ELIMINATE THE PROBLEM?"

  Patient problems: Bone Fracture(s)

  MAUDE report 16886526 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  PATIENT WAS REVISED DUE TO CHRONIC INFECTION, PAIN, HEALTH ISSUES AND MULTIPLE FALLS, THE IMPLANT WERE REMOVED. NO OTHER INFORMATION. NO SURGICAL DELAY WAS THERE. DOI: (B)(6) 2018. DOR: (B)(6) 2022, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15987526 ↗
• InjuryNov 2, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  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: Bone Fracture(s); Unspecified Infection

  MAUDE report 12740708 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT EVERYTHING WAS REMOVED DUE TO INFECTION. THERE WAS NO EXTENSION TO THE SURGICAL TIME AS THIS WAS A REVISION SURGERY.

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

  MAUDE report 12143107 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FELL, SUSTAINING A MID-SHAFT PERI-PROSTHETIC HUMERAL FRACTURE, APPROXIMATELY 4 DAYS AGO. GLENOID COMPONENTS (METAGLENE, GLENOSPHERE, SCREWS) ALL FOUND TO BE WELL FIXED AND FUNCTIONAL. LEFT INSITU. HUMERAL COMPONENTS REMOVED. LONG STEM REVISION DELTA PROSTHESIS CEMENTED IN, SYNTHES CABLE PLATE FIXED TO OUTSIDE OF HUMERUS, FULL LENGTH. NO AE REPORTED, NO DELAY IN THE SURGERY. THE PATIENT OUTCOME IS STABLE.

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

  MAUDE report 9939137 ↗
• MalfunctionFeb 21, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2009; PATIENT UNDERWENT REVISION OF RIGHT HEMIARTHROPLASTY TO A REVERSE TOTAL SHOULDER ARTHROPLASTY USING A DELTA XTEND PROSTHESIS, DEPUY. ON (B)(6) 2014; AT FIVE-YEAR FOLLOW-UP, PATIENT CONTINUES TO HAVE SOME PAIN IN HER RIGHT SHOULDER. X-RAYS REVEALED ZONE ONE LOOSENING IN THE HUMERUS. PATIENT HAS HAD NO REVISION THUS FAR AND IS TO FOLLOW-UP AGAIN IN TWO YEARS. PMH: DEPRESSION, FIBROMYALGIA, GASTRIC REFLUX, GOUT/PSEUDO-GOUT, HYPERTENSION, HIGH CHOLESTEROL, MIGRAINES, OSTEOARTHRITIS, OSTEOPENIA, ANXIETY AND THYROID DISEASE. DOI: (B)(6) 2009 (REVISION TO DELTA XTEND), DOE: (B)(6) 2014.

  Patient problems: Pain

  MAUDE report 9738496 ↗
• InjuryJul 2, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  CEMENTED HUMERAL STEM REVISION, BOWEN HOSPITAL (B)(6) 2019; PRIMARY IMPLANT DATE: 2016. THE REASON FOR THE REVISION WAS DUE TO A LOOSE STEM WHICH FAILED AT THE CEMENT-IMPLANT INTERFACE, AND A NON UNION GT. OLD STEM WAS REMOVED ALONG WITH THE CEMENT AND GT BONE FRAGMENTS. A NEW LONG STEM WAS IMPLANTED AND CEMENTED IN.

  Patient problems: No Code Available

  MAUDE report 8754076 ↗
• InjuryMar 25, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE HUMERAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKOWN. IT WAS ALSO REPORTED THAT THE PATIENT PRESENTED INFECTION AND SURGEON DECIDED TO REMOVE PROSTHESIS AND INSERT ANTIBIOTIC SPACER. DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT SHOULDER.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8447970 ↗
• InjuryFeb 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR UNEXPLAINED SHOULDER PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8296883 ↗
• InjuryNov 27, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE HUMERAL COMPONENT AT CEMENT TO IMPLANT INTERFACE.

  Patient problems: No Code Available

  MAUDE report 8106043 ↗
• InjurySep 11, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE UNKNOWN COMPONENT AT BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. ORIGINAL FX REVERSE. CAME BACK INFECTED AND DOING A 2 STAGE. ABX SPACER IMPLANTED. ALL PARTS REMOVED. DON'T HAVE PART NUMBER OR LOT ON DEPUY 2 CEMENT. DOI: (B)(6) 2017; DOR: (B)(6) 2018; UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 7863770 ↗
• InjuryAug 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ORIGINAL SURGERY WAS A CEMENTED REVERSE TOTAL SHOULDER ARTHROPLASTY FOR PROXIMAL HUMERUS FRACTURE, PATIENT THEN FRACTURED DISTAL TO THE TIP OF THE STEM AND SURGEON PLATED THE FRACTURED. EVENTUALLY THAT REPAIR FAILED AND BONE BEGAN TO RESORB. WE TOOK OUT STEM AND PE CUP TODAY AND USED A HUMERAL ALLOGRAFT NEW BONE AND NEW IMPLANTS ON THE HUMERAL SIDE. DOI: 2011; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 7770032 ↗
• InjuryJun 5, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN. SURGEON SUSPECTED LOOSENING OF PROSTHESIS. UPON REVISION ALSO FOUND SOME MEDIAL WEAR ON THE POLY FROM SOME SUSPECTED NOTCHING. REMOVED ENTIRE PROSTHESIS AND ASSOCIATED PARTS. LOOSENING OF THE HUMERAL STEM AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER USED WAS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT SHOULDER.

  Patient problems: Not Applicable; Pain

  MAUDE report 7568925 ↗
• InjuryMay 24, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND OSTEOLYSIS. DELTA EXTEND AND ALL COMPONENTS WERE REMOVED. LOOSENING AT THE STEM TO METAGLENE. CEMENT MANUFACTURER USED WAS UNKNOWN. DOI: 2008; DOR: (B)(6) 2018; RIGHT SHOULDER.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 7540533 ↗
• InjuryApr 19, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  DER STATES THAT THE PATIENT FELL ON RIGHT SHOULDER APPROXIMATELY 1 YEAR AGO FOLLOWING REVERSE TSA. IT WAS ALSO REPORTED THAT THERE WAS A LOOSENING OF THE STEM AT THE BONE TO CEMENT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2016; DOR: (B)(6) 2018. RIGHT SHOULDER.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7442696 ↗
• InjuryFeb 23, 2018Malposition of Device; Malposition of Device

  REVISED DUE TO PAIN AND IMPINGEMENT. THE INFERIOR SCREW HAD SNAPPED, PROBABLY DUE TO MECHANICAL NOTCHING. REVISED TO A 42 ECCENTRIC GLENOSPHERE AND 42/9 HMO POLY. SIGNIFICANT LYSIS AROUND BOTH COMPONENTS AS A RESULT OF THE MECHANICAL NOTCHING.

  Patient problems: Joint Disorder; Pain

  MAUDE report 7292071 ↗

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-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-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-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-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.
• 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-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-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.