ASPHERE 1365-42-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295033769), received between Oct 8, 2018 and Mar 17, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THERE WAS NO REVISION REPORTED. PRIMARY SURGERY NOTES AND PRIMARY SURGERY IMPLANT STICKER SHEETS WERE PROVIDED. ORTHOPEDIC CONSULTATION REPORT DATED (B)(6) 2013 INDICATES THAT THE PATIENT HAD A SLIGHT LEG LENGTH DISCREPANCY ON THE RIGHT HIP. IT IS NOT KNOWN IF THE IMPLANTS ON THE RIGHT HIP ARE FROM DEPUY. CLINIC VISIT ON (B)(6) 2013 REPORTS LOWER BACK PAIN, STIFFNESS, TINGLING AND NUMBNESS ALONG WITH RIGHT SIDED PARAVERTEBRAL MUSCLE TENDERNESS AND A PALPABLE MUSCLE SPASM. IT WAS MENTIONED THAT THE RIGHT HIP WAS PREVIOUSLY REVISED DUE TO WEAR. DOI: (B)(6) 2010; DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Discomfort; Hypoesthesia; Muscle Spasm(s); No Code Available; Pain

  MAUDE report 9845933 ↗
• InjuryOct 8, 2018Biocompatibility; Biocompatibility

  LITIGATION PAPERS ALLEGE THE FOLLOWING: AFTER THE SURGERY, FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND COBALT-CHROMIUM METAL LINER CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENT'S BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. AS A RESULT, PATIENT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS LEFT THIGH AND GROIN. HE ALSO EXPERIENCED A POPPING AND SNAPPING SENSATION IN HIS HIP-JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. HE ALSO EXPERIENCES NUMBNESS AND SWELLING IN HIS LEFT FOOT. HE ALSO SUFFERS FROM A LACK OF MOBILITY, INCLUDING WALKING WITH A LIMP AND THE NEED TO USE A CANE. UPDATE AD 01 MAY 2018: RECEIPT OF PPF AND STICKER SHEETS. THERE IS NO NEW ALLEGATION AND REVISION REPORTED. UPDATED PRODUCT AND LOT NUMBERS OF THE IMPACTED PRODUCTS.

  Patient problems: Discomfort; Hypoesthesia; Inflammation; Limited Mobility Of The Implanted Joint; Pain; Test Result

  MAUDE report 7944040 ↗