PRIME P2LXLC36Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684P2LXLC361), received between Sep 14, 2022 and Sep 14, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Unstable” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2022Unstable; Unstable

  (B)(4). ALLEGEDLY, REPORTS CONTINUED DRAINAGE FOR HIS RIGHT HIP WOUND. ADDITIONALLY, HE COMPLAINTS OF TIREDNESS AND FATIGUE BUT DENIES ANY SUBJECTIVE FEVERS. HE FEELS THE WOUND DRAINAGE IS REMAIN UNCHANGED IN VOLUME SINCE HIS LAST VISIT 2 DAYS AGO. PHYSICAL EXAMINATION: ALERT, COOPERATIVE ORIENTED 1 CM ONE DEFECT CONTINUED DRAINAGE SURROUNDING ERYTHEMA NO PAIN WITH GENTLE RANGE OF MOTION NVI. INVESTIGATIONS: X-RAY: NO EVIDENCE OF SUBSISTENCE FEMORAL HEAD CONCENTRIC WITHIN THE ACETABULAR CUP. IMPRESSION/PLAN: 3 WEEKS OUT FOR RIGHT TOTAL HIP ARTHOPLASTIC. UNFORTUNATELY HE HAD HAS SEVERAL INSTABILITY EVENTS WITH CONTINUED DRAINAGE FROM HIS RIGHT HIP WOUND. ADDITIONALLY, HE HAD A IL-6 LAB DRAWN ON MONDAY WHICH HAS COME BACK 18.6. GIVEN HIS 3 WEEKS OUT THIS NUMBER SHOULD BE ROUGHLY NORMALIZED AROUND 10. BASED IN THESE FACTORS THERE IS A CONSIDERABLE CHANCE THAT PATIENT POTENTIALLY HAS A DEEP INFECTION. WILL ADMIT HIM WITH PLANS FOR IRRIGATION DEBRIDEMENT HAS POSSIBLE REVISION. (B)(4). ADDITIONAL INFORMATION RECEIVED FOR PRODUCTS AND LOTS ON DATE 08/23/2022

  Patient problems: Superficial (First Degree) Burn; Unspecified Infection

  MAUDE report 15419685 ↗