ELITE PLUS 9653-28-047Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295318835), received between Mar 30, 2020 and Mar 3, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2023Loss of or Failure to Bond; Naturally Worn; Loss of or Failure to Bond; Naturally Worn

  REVISED A THR OF C-STEM AND MARATHON CEMENTED CUP FROM APPROXIMATELY 20 YEARS AGO. ORIGINAL SURGEON WAS DR AND THE OPERATION WAS AT QEII JUBILEE HOSPITAL. PRIMARY REASON FOR REVISION WAS FOR INSTABILITY/LOOSENING OF THE CUP. ONCE THE PT WAS OPEN AND DISLOCATED THE SURGEON REMOVED THE HEAD FROM THE STEM. 28MM METAL HEAD +3 WITH 9/10 TAPER, THE HEAD APPEARED TO HAVE MINIMAL WEAR. DUE TO LIMITED SPACE AND ACCESS TO THE ACETABULUM THE SURGEON DECIDED TO REMOVE THE STEM. ONCE REMOVED THE STEM APPEARED TO HAVE MINIMAL WEAR WITH NIL SIGNS OF DAMAGE. SIZE 3 STD. THE CEMENT MANTLE FOR THE STEM REMAINED IN TACK AND WAS HAPPY TO KEEP IT FOR NEW AMT C-STEM. THE SURGEON THEN REMOVED THE MARATHON CEMENTED CUP. CUP REMOVED WITH CEMENT ATTACHED TO CUP, WITH MINIMAL OBVIOUS WEAR. UNSURE OF CUP SIZE AS NOT VISIBLE ON RIM. SURGEON THEN IMPLANTED A HYBRID ZIMMER ACETABULAR CUP AND LINER. THE SURGEON DOWNSIZED THE STEM FOR NEW CEMENT MANTLE AND ADJUSTMENT OF VERSION OF THE STEM. SIZE 2 HO C-STEM AMT. CERAMIC 36MM +1.5MM HEAD IMPLANTED. GOOD STABILITY AND IMPROVED LEG LENGTH DISCREPANCY.

  Patient problems: Joint Laxity; Physical Asymmetry

  MAUDE report 16477253 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2013 VIA THA. IT WAS REPORTED THAT THERE WAS AN INDICATION OF INFECTION FOR SEVERAL YEARS, AND THE SURGEON HAD ADMINISTERED ANTIBIOTIC TO THE PATIENT AND FOLLOWED INFECTION¿S PROGRESS. HOWEVER, ON (B)(6) 2020, THE REMOVAL SURGERY WAS PERFORMED. THE SURGEON REMOVED THE CUP (P/N: 965328047), THE HEAD (P/N: 962734000), THE C-STEM (P/N: 961315000), THE CENTRALIZER (P/N: 961246000), THE END CAP (P/N: 961226000) AND THE CEMENT RESTRICTOR (P/N: 546014000) AND PLACED A CEMENT SPACE MOLDS. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9900798 ↗