DELTA XTEND 130738106Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295027355), received between Oct 11, 2017 and Oct 15, 2025 — classified as 19 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 23296107 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD C. ACNES INFECTION AS WELL AS PAIN AND JOINT INSTABILITY. THIS IS PATIENT'S SECOND REVISION.

  Patient problems: Joint Laxity; Pain; Unspecified Infection

  MAUDE report 22125091 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTED SHOULDER. ALL IMPLANTS REMOVED AND ANTIBIOTIC SPACER PLACED. NO DELAYS IN SURGERY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER

  Patient problems: Unspecified Infection

  MAUDE report 21079590 ↗
• InjuryDec 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT GLENOSPHERE (SHORT SCREW) CANNOT BE IMPLANTED. THE GLENOSPHERE SCREW CANNOT BE IN METAGLENE HOLE. SHORT SCREW PREVENTS VIEW AND FEEL OPTION. SOFT TISSUE FOLD IS NOT VISIBLE. THE PATIENT EXPERIENCED LUXATION OF SHOULDER JOINT SAME DAY POST OP AND REQUIRED REVISION SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 20914188 ↗
• 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 19384346 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 18483550 ↗
• InjurySep 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON BELIEVED THE PATIENT HAD A FALL AND DISLOCATED HER SHOULDER. HE DECIDED TO REMOVE THE CURRENT CUP AND REPLACE WITH A THICKER ONE FOR STABILITY. TIME WAS NOT DELAYED AND NOTHING SEEMED TO BE WRONG WITH ANY OF OUR IMPLANTS. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 17743680 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 17577069 ↗
• InjuryAug 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO CEMENT USED.

  Patient problems: Joint Dislocation

  MAUDE report 12359744 ↗
• InjuryJul 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS A RECENT DISLOCATION. THE PATIENT HAD A PRIOR REVERSE CONSTRUCT FOR FRACTURE. DOI: (B)(6) 2021. DOR: (B)(6) 2021. RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 12121703 ↗
• InjuryDec 23, 2020Naturally Worn; Naturally Worn

  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: Pain

  MAUDE report 11065248 ↗
• MalfunctionJul 21, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT SURGEON HAD GREAT EXPOSURE AND VISIBILITY. WHEN IMPACTING THE POLY, IT APPEARED TO LOCK IN BUT WAS EASILY LIFTED OUT WITH A FREER ELEVATOR. THE SURGEON REPEATED AND WASN'T COMFORTABLE WITH THE STABILITY OF THE LINER. HE RAN DOWNSTAIRS AND GRABBED ANOTHER LINER. THE SECOND POLY LOCKED IN PLACE LIKE NORMAL. NEED A REPORT BACK TO GIVE THE HOSPITAL AS TO WHETHER THE LOCKING MECHANISM WAS DEFECTIVE OR WAS THERE ANOTHER REASON WHY IT WOULDN'T PROPERLY ENGAGE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10300857 ↗
• 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) MEMORIAL 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:

  Patient problems: No Code Available; Pain

  MAUDE report 10237683 ↗
• InjuryMar 4, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT SHOULDER.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9787895 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ARTHROPLASTY HAS DISLOCATED THE REVERSE SHOULDER REPLACEMENT AND WILL BE REVISED FOR INSTABILITY.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8256555 ↗
• InjuryJan 9, 2019Material Erosion; Material Erosion

  PATIENT WAS REVISED TO ADDRESS SHOULDER PAIN AND LACK OF MOBILITY. DURING THE REVISION SURGERY, INSIDE THE CAPSULE THE INFERIOR LOCKING SCREW WAS REMOVED DUE TO IT ERODING THE HUMERAL CUP. NO SCREW WAS USED TO REPLACE IT. A +9 MM SPACER AND A 38 +6 RETENTIVE CUP WERE USED TO GAIN APPROPRIATE STABILITY. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT SHOULDER.

  Patient problems: Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8231245 ↗
• MalfunctionAug 21, 2018Fitting Problem; Fitting Problem

  POLLY CUP 38+6R WOULD NOT SEAT IN EPIPHYSIS. PATIENT CONSEQUENCE? NO. ACTION TAKEN FOR PROCEDURE: OPENED ANOTHER IMPLANT AND IT WORKED. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7801120 ↗
• InjuryJan 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PRIMARY (B)(6) 2017, REVISION (B)(6) 2017, REVISION (B)(6) 2017, REVISION (B)(6) 2017. RECURRENT DISLOCATION POST RTSJR. THIS IS THE THIRD REVISION OF THIS JOINT REPLACEMENT. SECOND REVISION INCLUDED USE OF A RETENTIVE SPACER. THERE WAS NO ISSUE WITH VERSION OF THE CEMENTED STEM IN SITU (AS PER SURGEON). THIS WAS LEFT IN SITU AND THE LINER AND GLENOSPHERE WERE UPSIZED. IT WAS SUGGESTED THAT THE DISLOCATIONS WERE POSSIBLY ANTERIOR. THE SURGEON POSITIONED AN ECCENTRIC GLENOSHERE MORE ANTERIORALLY DESPITE BEING INFORMED THEY WERE NOT MEANT TO BE USED IN THIS WAY AND A TRIAL WOULD NOT BE POSSIBLE. THE SHOULDER WAS REDUCED SUCCESSFULLY AND THE SURGEON REPORTED STABILITY BY THE FINISH OF THE PROCEDURE.

  Patient problems: Joint Dislocation

  MAUDE report 7206483 ↗
• InjuryDec 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS TRAUMATIC DISLOCATION AND STEM LOOSENING. LOOSENING OCCURRED AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. IT WAS ALSO INDICATED THAT THE STEM WAS RE-CEMENTED IN THE CANAL AND POLY WAS EXCHANGED. DOI: (B)(6) 2017; (B)(6) 2017; LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 7135338 ↗
• InjuryOct 25, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DER STATES THAT THE PATIENT HAD A DEPUY DELTA EXTEND IMPLANTED. PREVIOUSLY DISLOCATED AND WAS REVISED. PATIENT DISLOCATED AGAIN AND WAS REFERRED TO CURRENT SURGEON. THE SURGEON THEN REVISED THE HUMERAL STEM, CUP AND GLENOSPHERE TO ACHIEVE STABLE CONSTRUCT.

  Patient problems: Joint Dislocation

  MAUDE report 6975737 ↗
• InjuryOct 11, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DER STATES THAT THE PATIENT DISLOCATED AND IT WAS ALSO REPORTED THAT THE PATIENT PRESENTED AGAIN WITH DISLOCATION. SURGEON SHARED DURING PROP THAT THE PATIENT HAS LITTLE TO NO SOFT TISSUE SUPPORT. THEY REMOVED THE BELOW COMPONENTS AND IMPLANTED A DELTA XTEND CTA.

  Patient problems: Joint Dislocation

  MAUDE report 6940595 ↗

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-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-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-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-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-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-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-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.