NA 611.105.01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982250728), received between Jan 15, 2019 and Nov 14, 2022 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Slipped” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2022Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE CERCLAGE BRAIDED CABLES PROXIMALLY WERE LOOSE AND CREATING METALOSIS, SO IT WAS EXCISED. THE TROCHANTER IS COMPLETELY NON UNITED, BUT MORE LIKE A TROCHANTERIC SLIDE. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE 1.7 COCR CABLE WITH TI CRIMP 750-STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Metal Related Pathology; Nonunion/Delayed-union Bone Fracture

  MAUDE report 15794298 ↗
• InjuryNov 14, 2022Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE CERCLAGE BRAIDED CABLES PROXIMALLY WERE LOOSE AND CREATING METALOSIS, SO IT WAS EXCISED. THE TROCHANTER IS COMPLETELY NON UNITED, BUT MORE LIKE A TROCHANTERIC SLIDE. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 1.7 COCR CABLE WITH TI CRIMP 750-STERILE THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Metal Related Pathology; Nonunion/Delayed-union Bone Fracture

  MAUDE report 15792513 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 REMOVAL OF ORTHOPEDIC CABLES AND REVISION FIXATION DUE TO FRACTURE DISTAL TO FEMORAL STEM. UNKNOWN NUMBER OF CABLES REMOVED. THERE WAS THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THERE WAS NO FRAGMENTS GENERATED. THIS COMPLAINT INVOLVES ONE(1) DEVICE 1.7 COCR CABLE WITH TI CRIMP 750-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 14716028 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THIS IS REPORT 1 OF 9 FOR (B)(4).

  Patient problems: Bone Fracture(s); Failure of Implant; No Code Available

  MAUDE report 8620448 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT UNDERWENT FIRST REVISION LEFT HIP DUE TO ALLEGED INFECTION REQUIRING IV ANTIBIOTICS. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE DEPUY PINNACLE HIP SYSTEM (CUP, LINER, HEAD AND STEM) ON (B)(6) 2007. DURING THE REVISION SURGERY, THE DEPUY PINNACLE HIP SYTEM (CUP, LINER, HEAD AND STEM) WERE REMOVED, AND REPLACED WITH ZIMMER (CUP, LINER, HEAD AND STEM) ALONG WITH THE THREE (3) COBALT CHROME CERCLAGE CABLE WITH CRIMP TO SECURE IMPLANTS. IT WAS NOTED THAT AFTER THE REVISION THERE WAS STILL INFECTION REQUIRING IV ANTIBIOTICS. THE PROCEDURE AND PATIENT OUTCOMES WERE UNKNOWN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8570372 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT UNDERWENT FIRST REVISION LEFT HIP DUE TO ALLEGED INFECTION REQUIRING IV ANTIBIOTICS. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE DEPUY PINNACLE HIP SYSTEM (CUP, LINER, HEAD AND STEM) ON (B)(6) 2007. DURING THE REVISION SURGERY, THE DEPUY PINNACLE HIP SYTEM (CUP, LINER, HEAD AND STEM) WERE REMOVED, AND REPLACED WITH ZIMMER (CUP, LINER, HEAD AND STEM) ALONG WITH THE THREE (3) COBALT CHROME CERCLAGE CABLE WITH CRIMP TO SECURE IMPLANTS. IT WAS NOTED THAT AFTER THE REVISION THERE WAS STILL INFECTION REQUIRING IV ANTIBIOTICS. THE PROCEDURE AND PATIENT OUTCOMES WERE UNKNOWN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8570337 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT UNDERWENT FIRST REVISION LEFT HIP DUE TO ALLEGED INFECTION REQUIRING IV ANTIBIOTICS. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE DEPUY PINNACLE HIP SYSTEM (CUP, LINER, HEAD AND STEM) ON (B)(6), 2007. DURING THE REVISION SURGERY, THE DEPUY PINNACLE HIP SYTEM (CUP, LINER, HEAD AND STEM) WERE REMOVED, AND REPLACED WITH ZIMMER (CUP, LINER, HEAD AND STEM) ALONG WITH THE THREE (3) COBALT CHROME CERCLAGE CABLE WITH CRIMP TO SECURE IMPLANTS. IT WAS NOTED THAT AFTER THE REVISION THERE WAS STILL INFECTION REQUIRING IV ANTIBIOTICS. THE PROCEDURE AND PATIENT OUTCOMES WERE UNKNOWN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8570312 ↗
• InjuryMar 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, BEFORE THE PATIENT DISCHARGE FROM THE HOSPITAL, THE PATIENT FOUND TO HAVE A DEEP VEIN THROMBOSIS (DVT) IN THE LEFT LEG. WHEN THE PATIENT GOT HOME, THE PATIENT DEVELOPED SOME SORT OF UNKNOWN RASH OVER ALL OF THE BODY AND WAS FOUND TO HAVE FOUR (4) SMALL PULMONARY EMBOLI EVEN THOUGH HE HAS BEEN ASYMPTOMATIC. OVERALL, THE PATIENT IS IN A GOOD PLACE POSTOPERATIVELY AND IS DOING WELL. THE PATIENT ALSO HAS NEUROVASCULAR INTACT DISTALLY (NVID) AND GAIT WITH ANTALGIA DURING PHYSICAL EXAMINATION. THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION ON (B)(6) 2018 DUE TO PAIN OF HIP JOINT PROSTHESIS AND REPLACE IT WITH A STERILE CERCLAGE CABLE WITH CRIMP 1.77 MM COBALT-CHROME ALLOY. CONCOMITANT DEVICES REPORTED: NON SYNTHES DEVICE CEMENT BONE SIMPLEX (PART 6191-1-010, LOT RMY203, QUANTITY 2), NON SYNTHES DEVICE ADAPTER KNEE FEMUR (PART 960781, LOT HZ0266, QUANTITY 1), NON SYNTHES DEVICE ADAPTER KNEE BOLT SIGMA (PART 961784, LOT HZ3680, QUANTITY 1), NON SYNTHES DEVICE UNIVERSAL FEMORAL SLEEVE (PART 129453246, LOT 656290, QUANTITY 1), NON SYNTHES DEVICE FEMUR NON-POROUS REVISION LEFT (PART 960082, LOT HP0323, QUANTITY 1), NON SYNTHES DEVICE DISTAL AUGMENT PCF

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8396414 ↗
• InjuryJan 15, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN UNKNOWN PROCEDURE TO FIX A LEFT FEMUR FRACTURE, THE SURGEON DECIDED HE NEEDED SOME CABLE TO HELP REDUCE THE FRACTURE, BRING IT TOGETHER. ONCE HE PASSED THE CABLE WITH THE CABLE PASSER, PULL THE CABLE OUT THE OTHER END, PUT THE CABLE TO THE ISLET HE PASS IT THROUGH AGAIN AND TRY TO TENSION THE DEVICE BUT WAS NOT ABLE TO GET THE CABLE ALL THE WAY THROUGH. THE 1.7 CO CHROME CABLE BECAME STUCK IN THE CABLE TENSIONING DEVICE WHEN THE SURGEON TRIED TO PASS IT THROUGH THE INSTRUMENT. THEY HAD TO BARREL ON THE TENSIONING CABLE AND THEY GRAB A COMPETITIVE KIRSCHNER WIRE TO COMPLETE THE CABLE PRACTICE. THERE WAS A SURGICAL DELAY OF THREE TO FIVE MINUTES. THERE WAS NO HARM TO THE PATIENT AND PATIENT OUTCOME WAS STABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICES: CABLE PASSER (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) CABLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8248185 ↗