Lineage 36452801Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M684364528011), received between Jan 27, 2022 and May 7, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2025Naturally Worn; Naturally Worn

  ALLEGEDLY, THE DOCTOR REPORTS THAT THE PATIENT HAS EVIDENCE OF EARLY POLYETHYLENE WEAR; HE HAS NOT YET SCHEDULED REMOVAL OF THE MATERIAL. RELATED MPO PRODUCTS: PRODUCT ID: 36430046 LINEAGE® ACETABULAR SHELL 46MM QUAD HEMI FLARE STD GROUP 1/ LOT NO.: 16453831657950/ QTY: 1 PRODUCT ID: 26012802 COCR FEMORAL HEAD 28MM SLT TAPER +0MM NECK/ LOT NO.: 1694225/ QTY: 1 PRODUCT ID: 18080301 CANCELLOUS 6.5MM SELF-TAPPING BONE SCREW 2.0CM LENGTH/ LOT NO.: 1718278/ QTY: 1 PRODUCT ID: 18080301 CANCELLOUS 6.5MM SELF-TAPPING BONE SCREW 2.0CM LENGTH/ LOT NO.: 1711513/ QTY: 1 PRODUCT ID: PHA0CLS3 PROFEMUR® Z CLASSIC STEM SZ 3 STRAIGHT SHORT NECK/ LOT NO.: 1737747/ QTY: 1.

  Patient problems: Insufficient Information

  MAUDE report 21978197 ↗
• InjuryApr 30, 2025Naturally Worn; Naturally Worn

  ALLEGEDLY, THE DOCTOR REPORTS THAT THE PATIENT HAS EARLY POLYETHYLENE WEAR AND OSTEOLYSIS OF THE FEMUR.

  Patient problems: Osteolysis

  MAUDE report 21938779 ↗
• InjuryFeb 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, INTRA-ARTICULAR METALLOSIS SECONDARY TO TRUNNION WEAR, OSTEOLYSIS, PSEUDOTUMOR AND PROXIMAL PERI-PROSTHETIC FRACTURE.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 18673317 ↗
• InjuryJan 27, 2022Difficult to Insert; Difficult to Insert

  ALLEGEDLY, AT THE MOMENT OF IMPACTING THE INSERT INSIDE THE ACETABULAR CUP, IT DID NOT REMAIN FIXED, IT WAS TRIED THREE TIMES. THE SUPPORT WAS INDICATED TO PUT THE INSERT IN SALINE SOLUTION, IN SOME CASES THE POLYETHYLENE CAN EXPAND DUE TO HEAT AND SOAKING IT IN SALINE SOLUTION IS A GOOD TIP. THE INSERT WAS IMPACTED AGAIN AND IT WAS STABLE, THEN THE HIP WAS REDUCED AND AT THAT MOMENT THE DOCTOR OBSERVED THAT THE INSERT MOVED OUT OF POSITION, HE MOVED IT WITH HIS FINGERS AND FINISHED THE PROCEDURE. THE DOCTOR STATES THAT HE WAS LEFT WITH MANY DOUBTS AND SAYS THAT THERE IS A RISK OF DISLOCATION SINCE IT WAS NOT STABLE. SO FAR THE PATIENT IS WELL AND HAS NOT PRESENTED ANY INCONVENIENCE, WE CONTINUE TO FOLLOW UP.

  Patient problems: Insufficient Information

  MAUDE report 13370584 ↗