Series 7000 7115-0009Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327033373), received between Jun 27, 2018 and Jun 13, 2024 — classified as 13 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2024Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration

  PATIENT CAME TO DR. IN (B)(6) 2018 WITH COMPLAINTS OF ONGOING LEFT KNEE PAIN FOR ABOUT 1 YEAR. OVER THE LAST YEAR WITH INCREASING INSTABILITY, CLICKING AND BUCKLING FEELING. REVISED TO A TRIATHLON KNEE (B)(6) 2018 WITH COLLAPSED TIBIA NOTED.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 19528876 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION FROM SCORPIO IMPLANTS TO TS KNEE.

  Patient problems: Bone Fracture(s); Insufficient Information; Osteolysis

  MAUDE report 18158036 ↗
• InjuryJul 6, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO MECHANICAL LOOSENING (CLARIFIED AS THE TIBIAL BASEPLATE 'TIPPING' INTO VARUS). A SCORPIO KNEE WAS REVISED TO A TRIATHLON TS KNEE. REP PROVIDED REVISION USAGE AND EXPLANT PICTURES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14926713 ↗
• InjuryApr 21, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. THE ORIGINAL PLAN WAS TO PERFORM A POLY SWAP. HOWEVER, INTRA-OPERATIVELY, THE TIBIAL COMPONENT WAS FOUND LOOSE. BECAUSE THE SURGEON WANTED A HIGHER LEVEL OF CONSTRAINT, THE ENTIRE SCORPIO CONSTRUCT WAS REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11699006 ↗
• InjuryJun 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE PATIENT HAD AN INFECTION IN A JOINT WHICH HAD PREVIOUSLY BEEN IMPLANTED WITH A SCORPIO NRG. THE JOINT REQUIRED A WASH OUT. THE CUSTOMER REPORTED THAT THE PS POLY NEEDS REPLACING BUT THAT NO REVISION HAS TAKEN PLACE CURRENTLY

  Patient problems: Unspecified Infection

  MAUDE report 10188984 ↗
• InjuryOct 15, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT. THE PATIENT'S ENTIRE SCORPIO CONSTRUCT WAS REVISED TO A TRIATHLON TS CONSTRUCT. REP PROVIDED X-RAYS, PICTURES OF THE EXPLANTS, AND THE REVISION IMPLANT SHEET AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9192773 ↗
• InjuryAug 9, 2019Osseointegration Problem; Insufficient Device Problem Information; Osseointegration Problem; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO FAILED TIBIAL COMPONENT, RIGHT TOTAL KNEE REPLACEMENT.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8878691 ↗
• InjuryMay 1, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "LOOSE RIGHT TOTAL KNEE REPLACEMENT".

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8570371 ↗
• InjuryNov 29, 2018Unstable; Unstable

  STUDY: TOTAL KNEE REPLACEMENT LEFT SIDE ON 12 SEP 2011. ON 04 OCTOBER 2018 PATIENT REPORTS INSTABILITY DUE TO POSTERIOR CRUCIATE INSUFFICIENCY OF THE LEFT KNEE. KNEE BRACE TO TREAT THE EVENT.

  Patient problems: Injury

  MAUDE report 8117655 ↗
• InjuryOct 3, 2018Migration; Migration

  AS REPORTED: "REVISION OF LEFT TOTAL KNEE DUE TO SUBSIDED TIBIAL TRAY".

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7930907 ↗
• InjurySep 26, 2018Osseointegration Problem; Migration; Osseointegration Problem; Migration

  REVISED FOR LOOSENING OF TIBIAL TRAY.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7912123 ↗
• InjuryJul 11, 2018Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED BY THE PATIENT TO THE LEGAL DEPARTMENT VIA TELEPHONE THAT FOLLOWING HIS LEFT KNEE SURGERY, HE EXPERIENCED A BOWED LEG EFFECT, PAIN AND SWELLING. HE HAD A COMPLETE REVISION ON (B)(6) 2014 AND AS PER DR. (B)(6), HIS KNEE "FAILED CATASTROPHICALLY". LEFT KNEE. UPDATE PER MEDICAL REVIEW: ¿ON (B)(6) 2014 A REVISION OF THE LEFT TOTAL KNEE ARTHROPLASTY WAS PERFORMED FOR A DIAGNOSIS OF "FAILED LEFT TKA". THE OPERATIVE REPORT DESCRIBES THE USE OF A TOURNIQUET AND NOTES, "FEMORAL COMPONENT CLEARLY LOOSE, TIBIA LOOSE AND PUNCHED OUT EASILY. DEBRIDED GRANULOMATOUS TISSUE ... SUBSTANTIAL BONE LOSS, CYSTIC AREA SCRAPED OUT." A ZIMMER CONE FOR THE TIBIAL WAS PREPARED WITH A MIDIS REX TO ALLOW FOR A #8 TRIATHLON TIBIAL BASEPLATE WITH A 15MM STEM AND A 10MM FULL BLOCK AUGMENT. A #7 TS FEMORAL COMPONENT WITH A 15MM DISTAL AUGMENT, A 10MM. POSTERIOR AUGMENT AND A MEDIUM ZIMMER CONE WAS UTILIZED. A #8/11 TS INSERT WAS PLACED IN THE TIBIA UNCOMPLICATED SURGERY WAS DESCRIBED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2014. SURGICAL PATHOLOGY FINAL DIAGNOSIS WAS "FOREIGN BODY GIANT CELL REACTION TO CEMENT MATERIAL CONSISTENT WITH FAILED JOINT PROSTHESIS".¿

  Patient problems: Inadequate Osseointegration; Injury; Pain; Swelling

  MAUDE report 7680523 ↗
• InjuryJun 27, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO TIBIAL COMPONENT LOOSENING. PATIENT WAS REVISED TO A TRIATHLON TS KNEE. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7641303 ↗