NA 298.801.01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10886982182500), received between Oct 30, 2014 and Sep 16, 2024 — classified as 24 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2024Break; Break

  COMPLAINT RECEIVED FOR PATIENT WITH PERIPROSTHETIC FRACTURE THAT UNDERWENT SURGERY. SURGEON REPORTED THAT THE PATIENT HEALED NICELY. POSTOPERATIVELY, ONE OF THE CABLES BROKE AND WAS PROMINENT IN PATIENT'S DEEP SOFT TISSUE CAUSING PAIN IN THE MIDDLE THIRD OF THE THIGH. REMOVAL OF THE HARDWARE WAS SUCCESSFULLY COMPLETED WITHOUT ANY INTRAOPERATIVE OR POSTOPERATIVE COMPLICATIONS.

  Patient problems: Limb Pain

  MAUDE report 20224930 ↗
• InjuryJul 24, 2023Failure to Osseointegrate; Failure to Osseointegrate

  DPS EMAILED A COMPLAINT FORM ON 7-20-23 FOR AN INCIDENT THAT HAPPENED IN 2021, "ON (B)(6) 2021, THE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY WITH DISTAL REPLACEMENT. HARDWARE REMOVAL LEFT FEMUR DUE TO LEFT SUPRACONDYLAR/INTERCONDYLAR FEMORAL FRACTURE NONUNION, HARDWARE FAILURE AND OSTEOARTHRITIS LEFT KNEE. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT HAD A FALL. SHE WAS CLIMBING OVER LIKE A DOG GATE, TRIPPED AND FELL. SHE INITIALLY FELT PAIN IN HER LEFT KNEE. SHE WAS DIAGNOSED WITH A LEFT DISTAL FEMUR FRACTURE. ON (B)(6) 2021 THE PATIENT UNDERWENT LEFT DISTAL FEMUR OPEN REDUCTION AND INTERNAL FIXATION WITH A SYNTHES LATRERAL PLATE AND MULTIPLE CERCLAGE CABLES DUE TO LEFT DISTAL FEMUR COMMINUTED INTRA-ARTICULAR FRACTURE AND MORBID OBESITY. THIS COMPLAINT INVOLVES EIGHTEEN (18) DEVICES." ONLY 3 OF THE DEVICES ARE FROM RESOLVE SURGICAL.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17383656 ↗
• InjuryJul 24, 2023Failure to Osseointegrate; Failure to Osseointegrate

  DPS EMAILED A COMPLAINT FORM ON (B)(6) 2023 FOR AN INCIDENT THAT HAPPENED IN 2021, "ON (B)(6) 2021, THE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY WITH DISTAL REPLACEMENT. HARDWARE REMOVAL LEFT FEMUR DUE TO LEFT SUPRACONDYLAR/INTERCONDYLAR FEMORAL FRACTURE NONUNION, HARDWARE FAILURE AND OSTEOARTHRITIS LEFT KNEE. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT HAD A FALL. SHE WAS CLIMBING OVER LIKE A DOG GATE, TRIPPED AND FELL. SHE INITIALLY FELT PAIN IN HER LEFT KNEE. SHE WAS DIAGNOSED WITH A LEFT DISTAL FEMUR FRACTURE. ON (B)(6) 2021 THE PATIENT UNDERWENT LEFT DISTAL FEMUR OPEN REDUCTION AND INTERNAL FIXATION WITH A SYNTHES LATRERAL PLATE AND MULTIPLE CERCLAGE CABLES DUE TO LEFT DISTAL FEMUR COMMINUTED INTRA-ARTICULAR FRACTURE AND MORBID OBESITY. THIS COMPLAINT INVOLVES EIGHTEEN (18) DEVICES." ONLY 3 OF THE DEVICES ARE FROM RESOLVE SURGICAL.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17383625 ↗
• MalfunctionJan 30, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2022 THE SURGEON REMOVED A VA CONDYLAR FEMUR PLATE AND 6.5 CANNULATED SCREW ALONG WITH A STRYKER GAMMA NAIL IN ORDER TO PERFORM A DISTAL FEMUR REPLACEMENT AT A FUTURE DATE. THE VA CONDYLAR PLATE WAS USED TO TREAT A FEMUR FRACTURE ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.7MM CABLE WITH CRIMP 750MM-STERILE THIS IS REPORT 1 OF 1 FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264348 ↗
• MalfunctionAug 24, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JULY 26,2022 THAT THE 1.7MM CABLE WITH CRIMP 750MM-STERILE BECAME JAMMED IN THE CABLE TENSIONER DEVICE. THE CABLE HAD TO BE CUT AND ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THE CABLE WAS REMOVED FROM THE DEVICE IN A NON STERILE ENVIRONMENT. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS GENERATED. PATIENT WAS IN STABLE CONDITION. THIS REPORT IS FOR ONE 1.7MM CABLE WITH CRIMP 750MM-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15282107 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT SUSTAINED PERIPROSTHETIC FRACTURE (PPF) BELOW FEMORAL NAIL IN (B)(6) AND WAS FIXED WITH VA CONDYLAR PLATE ON AN UNKNOWN DATE IN (B)(6) 2022. PATIENT WAS READMITTED APPROXIMATELY 3 MONTHS AFTER IMPLANT WITH PLATE FRACTURE. NO NEW TRAUMA. HAD BEEN MOBILIZING IN RESIDENTIAL HOME. NORMAL TO LOW BMI. FRACTURE NON-UNITED, BUT NO EVIDENCE OF INFECTION. REVISION OCCURRED (B)(6) 2022. THIS IS REPORT 3 OF 11 FOR (B)(4). THIS REPORT IS FOR A CABLE WITH CRIMP. THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15076251 ↗
• MalfunctionJun 3, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE TENSIONING A CABLE AROUND A FEMUR, THE SURGEON EXCEEDED THE RECOMMENDED TENSIONING STRENGTH AND ULTIMATELY BROKE THE CABLE. THE CABLE WAS REMOVED, AND A NEW CABLE WAS PLACED. NO ADVERSE EVENTS OR COMPLAINTS AGAINST THE DEVICE WERE COMMUNICATED. THERE WAS PATIENT INVOLVEMENT. THERE WAS TEN MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE GENERATED AND THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THIS REPORT INVOLVES ONE 1.7MM CABLE WITH CRIMP 750MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14595836 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REMOVAL OF HARDWARE AND REVISION OF OPEN REDUCTION INTERNAL FIXATION(ORIF) LEFT FEMUR DUE TO FAILED FIXATION. LEFT HIP, FAILED DHS CONSTRUCT FOR SUBTROCH PROXIMAL FEMUR FRACTURE. THE ORIGINAL SURGERY WAS ON (B)(6) 2021. THIS REPORT IS FOR ONE (1) 1.7MM CABLE WITH CRIMP 750MM-STERILE. THIS IS REPORT 2 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12902607 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REVISION SURGERY. DURING THE SURGERY, THE HARDWARE WAS REMOVED FROM THE PATIENT'S FEMUR AND USED RIA TO GET BONE GRAFT FROM OPERATIVE FEMUR DUE TO A NONUNION FROM THE PREVIOUS SURGERY. SURGEON REVISED FEMUR USING A UNIVERSAL FEMORAL NAIL, AND A VA CONDYLAR PLATE. HE THEN PUT IN BONE GRAFT COLLECTED FROM RIA IN THE NONUNION SITE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S SURGERY WAS REVISED. THIS COMPLAINT INVOLVES FOURTEEN (14) DEVICES. THIS REPORT IS FOR (1) 1.7MM CABLE WITH CRIMP 750MM-STERILE. THIS REPORT IS 7 OF 14 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12515800 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REVISION SURGERY. DURING THE SURGERY, THE HARDWARE WAS REMOVED FROM THE PATIENT'S FEMUR AND USED RIA TO GET BONE GRAFT FROM OPERATIVE FEMUR DUE TO A NONUNION FROM THE PREVIOUS SURGERY. SURGEON REVISED FEMUR USING A UNIVERSAL FEMORAL NAIL, AND A VA CONDYLAR PLATE. HE THEN PUT IN BONE GRAFT COLLECTED FROM RIA IN THE NONUNION SITE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S SURGERY WAS REVISED. THIS COMPLAINT INVOLVES FOURTEEN (14) DEVICES. THIS REPORT IS FOR (1) 1.7MM CABLE WITH CRIMP 750MM-STERILE. THIS REPORT IS 2 OF 14 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12514295 ↗
• InjurySep 21, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A REMOVAL PROCEDURE, THE PLATE WAS REMOVED DUE TO BONE HEALING FAILURE. THIS WAS IMPLANTED ON (B)(6) 2021. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 1.7MM CABLE WITH CRIMP 750MM-STERILE THIS REPORT IS 8 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12505397 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A REMOVAL PROCEDURE, THE PLATE WAS REMOVED DUE TO BONE HEALING FAILURE. THIS WAS IMPLANTED NO (B)(6) 2021. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 1.7MM CABLE WITH CRIMP 750MM-STERILE. THIS REPORT IS 10 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12502328 ↗
• MalfunctionAug 6, 2021Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A CERCLAGE CABLE WITH CRIMP CABLE ON A FEMUR FRACTURE WAS RELEASED. THE ORIGINAL IMPLANT DATE WAS ON (B)(6) 2021. NO FURTHER ACTION IS PLANNED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) 1.7MM CABLE WITH CRIMP 750MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288121 ↗
• MalfunctionSep 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE CABLE TENSIONER IS BADLY FRAYED, AFTER CUTTING THE CABLE LOOSE FROM THE PATIENT AND IT FRAYED AND GOT STUCK IN THE TENSIONER. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO DAMAGE TO THE PATIENT. THIS REPORT IS FOR ONE (1) 1.7MM CABLE WITH CRIMP 750MM-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10553720 ↗
• InjuryMay 21, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT STATUS POST MECHANICAL FALL WITH COMPLAINTS OF RIGHT LEG PAIN AND INABILITY TO AMBULATE. RADIOGRAPHIC IMAGING IDENTIFIED A PERIPROSTHETIC FEMORAL SHAFT FRACTURE INDICATING THE PATIENT FOR THE AFOREMENTIONED SURGICAL STABILIZATION PROCEDURE. ON (B)(6) 2017, PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION OF FEMUR RIGHT SIDE. ON (B)(6) 2018, PATIENT WAS STILL HAVING PAIN AND X-RAYS REVEALED BROKEN PLATE AND FEMORAL NON-UNION. PATIENT HAD EVALUATION AND MANAGEMENT OF RIGHT HIP PAIN. SHE WAS SEEN BY OTHER SURGICAL TEAM ON (B)(6) 2018 AND DISCUSSED REVISION ORIF VS PFR/REVISION ARTHROPLASTY. ON (B)(6) 2019 X-RAYS REVEALED THE PLATE IS BROKEN AS WELL AS CERCLAGE CABLES AT THE LEVEL OF THE FRACTURE SITE. THE HARDWARE OBSCURES PORTIONS OF THE FRACTURE. ASSESSMENT OF THE DEGREE OF BONE BRIDGING IS DIFFICULT TO ASSESS. MILD VARUS ANGULATION AT THE FRACTURE LEVEL WAS ALSO NOTED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 1.7MM CABLE WITH CRIMP 750MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 10080776 ↗
• InjuryFeb 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO RTI SURGICAL ON (B)(6) 2020 THAT THERE WAS A PATIENT WHO UNDERWENT A REVISION ON AN UNKNOWN DATE DUE TO A 2 STAGE INFECTION RELATED TO A PREVIOUS HIP SURGERY. IT IS UNKNOWN WHEN INDEX SURGERY WAS PERFORMED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 9689886 ↗
• InjuryFeb 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO RTI SURGICAL ON (B)(6) 2020 THAT THERE WAS A PATIENT WHO UNDERWENT A REVISION ON AN UNKNOWN DATE DUE TO 2 STAGE INFECTION RELATED TO A PREVIOUS HIP SURGERY. IT IS UNKNOWN WHEN INDEX SURGERY WAS PERFORMED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 9689782 ↗
• InjuryNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A CONVERSION OF RIGHT HIP SURGERY TO TOTAL HIP REPLACEMENT. THE CAUSE FOR REVISION WAS INFECTION. THE PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 9353292 ↗
• InjuryNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A CONVERSION OF RIGHT HIP SURGERY TO TOTAL HIP REPLACEMENT. THE CAUSE FOR REVISION WAS INFECTION. THE PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 9353248 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CAUSE FOR REVISION WAS 2 STAGE INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9316856 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CAUSE FOR REVISION WAS 2 STAGE INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9316807 ↗
• 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 6 OF 9 FOR (B)(4).

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

  MAUDE report 8620505 ↗
• 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 4 OF 9 FOR (B)(4).

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

  MAUDE report 8620500 ↗
• 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 5 OF 9 FOR (B)(4).

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

  MAUDE report 8620498 ↗
• MalfunctionJul 11, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THREE (3) SEPARATE CABLE TENSIONERS HAVE A CABLE STUCK IN THE DEVICES. ISSUE WAS DISCOVERED AFTER AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND AFTER THE DEVICES WERE CLEANED. NO PATIENT HARM WAS REPORTED. THIS REPORT IS FOR ONE (1) CABLE WITH CRIMP. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7677575 ↗