Series 7000 7115-0007Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327033366), received between Dec 21, 2017 and May 19, 2022 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY THE SALE REP THAT SURGEON INFORMED THAT THERE'S A POSSIBLE REVISION SURGERY FOR KNEE REPLACEMENT DUE TO ASEPTIC LOOSENING AS PATIENT HAD THE KNEE IMPLANT FOR ABOUT 10 YEARS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14446463 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY HEALTH (B)(6) (VIA THE PATIENT) THAT AN INCIDENT REPORT HAD OCCURRED. IT WAS REPORTED THAT THE PATIENT ALLEGED "METALLOSIS WAS CONFIRMED VIA LABS IN (B)(6) 2020". IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A NUMBER OF HEALTH CONCERNS.

  Patient problems: Foreign Body Reaction

  MAUDE report 12335162 ↗
• InjuryJun 1, 2021Osseointegration Problem; Osseointegration Problem

  IN PERFORMING FOLLOW-UP FOR A PI, REP PROVIDED A REVISION OPERATIVE REPORT FOR (B)(6) 2012 FOR THE PATIENT'S RIGHT KNEE. PREOPERATIVE DIAGNOSIS: ASEPTIC LOOSENING RIGHT TOTAL KNEE REPLACEMENT. PATIENT WAS REVISED TO A TRIATHLON TS KNEE. AS PER SALES REP: "NOT SURE WHETHER IT WAS A SCORPIO OR A TRIATHLON."

  Patient problems: Inadequate Osseointegration

  MAUDE report 11911614 ↗
• InjuryApr 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "SUBSIDED TIBIAL TRAY RIGHT KNEE. REVISED RIGHT KNEE TO REVISION COMPONENTS."

  Patient problems: Insufficient Information

  MAUDE report 11704557 ↗
• InjurySep 24, 2020Loss of Osseointegration; Loss of Osseointegration

  RIGHT KNEE REVISION DONE ON (B)(6) 2020 DUE TO TIBIAL COMPONENT LOOSENING. ALL COMPONENTS WERE EXPLANTED. NO RETURN OF EXPLANTED IMPLANTS DUE TO HOSPITAL POLICY. DR. STATED HE WOULD HAVE PREFERRED TO DO A TIBIAL ONLY REVISION SINCE FEMUR WAS WELL FIXED BUT COMPATIBLE BASEPLATES ARE NO LONGER AVAILABLE FROM STRYKER. NO MORE INFORMATION WILL BE AVAILABLE PER DOCTOR.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10580300 ↗
• InjuryAug 26, 2020Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "THE FOLLOWING IMPLANTS WERE EXPLANTED FROM PATIENT'S LEFT KNEE DUE TO LOOSENING. INITIAL IMPLANT DATE WAS (B)(6) 2002. ALL INFORMATION THE FACILITY HAS ON THIS PATIENT IS ATTACHED. A TRIATHLON TS WAS INSERTED." REP PROVIDED PRIMARY USAGE SHEET A SCORPIO/ SERIES 7000 KNEE WAS REVISED.

  Patient problems: Injury

  MAUDE report 10455335 ↗
• InjuryMar 11, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE SUSTAINED IN A FALL. ALSO AS A RESULT OF THE FALL, THE TIBIAL BASEPLATE BECAME LOOSE. THE PATIENT'S SCORPIO KNEE WAS REVISED TO A HINGED KNEE. REP PROVIDED THE REVISION USAGE SHEET, PRE- AND POST-REVISION X-RAYS, CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Bone Fracture(s); Fall; Inadequate Osseointegration; Injury

  MAUDE report 9819151 ↗
• MalfunctionDec 21, 2017Material Deformation; Material Deformation

  THE CUSTOMER REPORTED THAT THE TIBIAL BASE PLATE WAS MARKED WHEN THEY TOOK IT OUT OF THE PACK. THE SURGEON CHOSE NOT TO USE THE DEVICE AND COMPLETED THE CASE WITH AN ALTERNATIVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7139928 ↗