C-STEM 9611-63-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295235200), received between Nov 20, 2020 and Nov 3, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Degraded” (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.

• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT A THA SURGERY FOR OA WITH THE IMPLANTS IN QUESTION. AFTER THE SURGERY IN (B)(6) 2024, X-RAYS SHOWED NO ABNORMALITIES IN THE LINER IN QUESTION. IN (B)(6) 2025, CT SCAN REVEALED SOME WEAR (ECCENTRICITY OF THE HEAD) MOVEMENT BEHIND THE LINER. ON (B)(6) 2025, THE PATIENT VISITED THE HOSPITAL COMPLAINING OF ABNORMAL NOISE AND PAIN. AN X-RAY REVEALED SIGNIFICANT DISPLACEMENT OF THE FEMORAL HEAD CENTER. DISLOCATION AND WEAR WERE SUSPECTED, BUT THE X-RAY FINDINGS DID NOT REVEAL DISLOCATION. THE SURGEON DOUBTED THAT SUCH EXTENSIVE WEAR COULD OCCUR IN SUCH A SHORT PERIOD OF TIME, AND SUSPECTED LINER DISLOCATION. ON (B)(6) A REVISION WAS SCHEDULED FOR (B)(6) 2025. DURING THE SURGERY, A SALES REPRESENTATIVE CHECKED THE SITUATION FROM THE SURGICAL FIELD AND CONFIRMED THE FOLLOWING: THE LINER AT THE TOP OF THE CUP RIM WAS EMBEDDED INTO THE CUP, WITH THE ANTI-ROTATION TAB DESTROYED. THE DELTA HEAD HAD COLLIDED WITH THE CUP RIM AND THE TAPERED LOCKING PORTION OF THE CUP/LINER (DISCOLORED DUE TO FRICTION WITH THE HEAD), CAUSING SIGNIFICANT DAMAGE. THE SURGEON DETERMINED THAT RE-FIXING THE LINERS WOULD BE DIFFICULT, SO ALL IMPLANTS PLACED IN

  Patient problems: Pain

  MAUDE report 23450100 ↗
• InjuryMar 2, 2023Naturally Worn; 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 16467188 ↗
• InjuryNov 20, 2020Degraded; Degraded

  THE PRIMARY SURGERY WAS PERFORMED ABOUT 15 YEARS AGO (THE DATE WAS UNKNOWN) AT ANOTHER HOSPITAL VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE STEM DUE TO THE DISLOCATION. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. THE SURGEON FOUND LIKE CORROSION ON THE REMOVED STEM. THERE WAS NO LOOSENING OF THE STEM AND CEMENT, NO SIGN OF INFECTION. THE CONDITION OF FIXATION WAS GOOD. THE SURGEON REQUESTED INVESTIGATION OF COMPONENT ANALYSIS OF CORRODED PARTS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Pain

  MAUDE report 10876550 ↗