PROFEMUR PPRCLS02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M684PPRCLS021), received between Apr 21, 2022 and Apr 29, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, SUBJECT RETURNED TO CLINIC FOR HER 6 WK STUDY VISIT AND STATED THAT SHE HAD BEEN USING A WHEELCHAIR FOR SEVERAL DAYS DUE TO PAIN IN HER IMPLANTED HIP. AN X-RAY INDICATED THAT THE HIP HAD BROKEN AND WHEN QUESTIONED, THE SUBJECT STATED THAT SHE IS NOT CERTAIN BUT MAY HAVE TAKEN A "LITTLE FALL" AT SOME POINT, THOUGH UNABLE TO SPECIFY WHEN. PI ADVISED SUBJECT TO PRESENT TO THE EMERGENCY DEPARTMENT WHERE SHE WAS LATER TRANSPORTED TO THE SURGICAL CENTER FOR REVISION SURGERY ON (B)(6) 2023.

  Patient problems: Bone Fracture(s)

  MAUDE report 19203662 ↗
• InjurySep 14, 2022Unstable; Unstable

  SAE #(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 ARTHROPLASTIC. 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. SAE #(B)(4). ADDITIONAL INFORMATION RECEIVED FOR PRODUCTS AND LOTS ON DATE 08/23/2022.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 15419800 ↗
• InjuryApr 21, 2022Loss of Osseointegration; Loss of Osseointegration

  (B)(6). ALLEGEDLY, SUBJECT UNDERWENT THE RIGHT SIDE ON (B)(6) 2020. SUBJECT EXPERIENCED PAIN STARTING IN (B)(6) 2020. PAIN CONTINUED THRU EARLY (B)(6)2020 WHEN MRI INDICATED THE FEMORAL COMPONENT MAY NOT HAVE GROWN IN PROPERLY. SUBJECT WAS ADMITTED TO HOSPITAL ON (B)(6) 2020 AND UNDERWENT REVISION THAT SAME DAY. DISCHARGED ON (B)(6)2020.

  Patient problems: Pain

  MAUDE report 14166473 ↗