Sleeve 17-0000ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327016468), received between Nov 6, 2018 and Jul 18, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY. AN ADM/ MDM POLY INSERT, MDM METAL LINER, CERAMIC HEAD AND SLEEVE AND 2 SCREWS WERE REVISED TO A CONSTRAINED LINER AND NEW FEMORAL HEAD. REP CONFIRMED THAT INTRA-OPERATIVELY NO IMPLANTS WERE NOTED TO BE WORN, LOOSE, OR DAMAGED.

  Patient problems: Joint Laxity

  MAUDE report 15046465 ↗
• InjuryOct 16, 2020Unstable; Unstable

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S LEFT HIP WAS REVISED. NOTED ON THE SHEET: "A METAL E MDM LINER AND MDM E POLY AND 28 +5 CERAMIC HEAD/ SLEEVE WERE REMOVED. REASON: INSTABILITY. NO FURTHER INFORMATION WILL BE GIVEN DUE TO HOSPITAL POLICY." A 22.2 +3 LFIT V40 HEAD AND 0° E CONSTRAINED INSERT WERE IMPLANTED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 10688715 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. SURGEON ALSO REPORTED THE EXISTENCE OF BULLET FRAGMENTS IN PATIENT'S HIP. A CORMET ENDOPROSTHESIS WITH SLEEVE AND CORMET 2000 HA CUP WERE REVISED.

  Patient problems: Injury; Pain

  MAUDE report 8362446 ↗
• InjuryDec 21, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PATIENT CALLED STATING SHE HAD A RIGHT HIP REPLACEMENT IN (B)(6) 2008, SHE STATED SHE HAD EXPERIENCED PAIN FOR SEVERAL YEARS AND PT HASN'T HELPED MUCH. PATIENT IS SCHEDULED FOR A REVISION SURGERY IN 2 WEEKS DUE TO LOOSENING OF STEM AND ELEVATED LEVELS OF COBALT AND CHROMIUM. UPDATE 30-NOV-2018: PATIENT WAS REVISED (B)(6) 2018. UPDATE 11/DECEMBER/2018: REP REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN, AND DUE TO METAL ON METAL BEARING SURFACE. INTRAOPERATIVELY, A LARGE PSEUDO-TUMOR WAS NOTED. ADDITIONAL UPDATE 11/DECEMBER/2018: REVISION OPERATIVE REPORT SUPPLIED BY REP INDICATED THE 46MM UNIPOLAR HEAD, SLEEVE, AND 3 CABLES WERE EXPLANTED AND "MDM WITH A 46MM OUTER DIAMETER AND 28MM +8 METALLIC HEAD" WERE IMPLANTED. UPDATE 22/APRIL/2019: MEDWATCH (MW5085656) RECEIVED, PATIENT REPORTED " [...] I WAS IN EXCRUCIATING PAIN FOR YEARS AND SUFFERED NUMEROUS HEALTH PROBLEMS INCLUDING AN UNEXPLAINED HEART ATTACK ON [...] 2017."

  Patient problems: Edema; Inflammation; Injury; Pain; Reaction

  MAUDE report 8190835 ↗
• InjuryNov 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS PER MEDICAL RECORDS FOR PER (B)(6) STATED THAT " AN OFFICE VISIT ON (B)(6) 2010 NOTES THE BIOPSY SHOWED "EOSINOPHILS CONSISTENT WITH ALLERGIC TYPE REACTION BUT NO EVIDENCE OF SARCOMA." ... THERE IS AN (B)(6) 2010 ADMISSION AND SURGERY FOR EXCISION OF THE RIGHT THIGH MASS AND EXPLANT OF THE RIGHT TOTAL HIP ARTHOPLASTY. ... A DISCHARGE SUMMARY DATED (B)(6) 2010 DESCRIBES ADMISSION ON (B)(6) 2010 FOR EXCISION OF MASS AND "DURING PROCEDURE WE DETERMINED THAT THE MASS HAD ACTUALLY TRANSFORMED MOST OF HER NORMAL TISSUE AROUND HIP JOINT INTO FIBROUS NECROTIC TISSUE, INCLUDING HER GLUTEUS MAXIMUS, MEDIUS AND MINIMUS, AND A LARGE PORTION OF HER SCIATIC NERVE ... DEAD MUSCLE ... EXCISED ... PROSTHESIS ... EXPLANTED ... MASS EXTENDED INTO PELVIS ... NOT RESECTED DUE TO DANGER ... PRE-OP MRI PELVIC MASS NONMALIGNANT" ... THE DIAGNOSIS WAS "ISCHEMIC FASCIITIS, POSSIBLE PSEUDOTUMOR".

  Patient problems: Cyst(s); Injury; Reaction

  MAUDE report 8043266 ↗