Lineage 36430056Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684364300561), received between Jan 6, 2022 and Nov 7, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Deformation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryNov 7, 2022Material Deformation; Material Deformation

  ALLEGEDLY, WHEN STARTING WITH THE ACETABULAR TIME AND AFTER PERFORMING THE RESPECTIVE CLEANING AND DEPTH TO THE ACETABULUM, THE FINAL 56 MM MICROPORT NON-CEMENTED CUP IS POSITIONED, IMPACTED, VERIFIED AND A SECOND IMPACTION IS PERFORMED. AFTER THAT, THE SPECIALIST POSITIONS THE DRILL FOR THE PLACEMENT OF THE SCREWS, POSITIONS THE FIRST OF THEM AND THE DAMAGE AND DEFORMATION OF THE CUP IS EVIDENCED. FROM THIS, THE CUP 56 IS EXTRACTED AND THE ANTERIOR CUP 54MM IS OPENED AND POSITIONED. SURGERY WAS DELAYED MORE THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15744552 ↗
• InjuryJan 6, 2022Appropriate Device Problem Term/Code Not Available

  SAE# (B)(4). ALLEGEDLY, THE PATIENT STARTED HAVING LT HIP PAIN 3 WEEKS AFTER SURGERY. MULTIPLE ATTEMPTS TO RELIEF THE PAIN WITH CORTICOSTEROID INJECTIONS INTRA-ARTICULAR WITH NO SUCCESS. THE PATIENT UNDERWENT A SURGICAL INTERVENTION FOR RELEASE OF THE PSOAS TENDON ON (B)(6) 2018. THE PAIN AND WEAKNESS IN THE LEFT THIGH IS STILL PERSISTENT. ADDITIONAL INFORMATION FROM CLINICAL RECEIVED ON 26/10/2021 CONFIRMING THAT COMPONENTS WERE NOT REVISED.

  Patient problems: Pain

  MAUDE report 13178534 ↗