Series 7000 7115-0004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327033335), received between Sep 4, 2019 and Apr 9, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2020Insufficient Device Problem Information; Difficult or Delayed Separation; Insufficient Device Problem Information; Difficult or Delayed Separation

  THIS IS TO INFORM YOU THAT FEMALE WAS OPERATED FOR BILATERAL SEVERE ARTHRITIS SECONDARY TO RHEUMATOID ARTHRITIS WITH STRYKER SCORPIO NRG IMPLANT ON (B)(6) 2018 (LEFT KNEE) AND (B)(6) 2018 (RIGHT KNEE) WITH (LEFT KNEE). AFTER A FEW MONTHS PATIENT PRESENTED WITH SYNOVITIS ON THE RIGHT SIDE AND PATIENT WAS PLANNED FOR SYNOVECTOMY ALONG WITH POLYETHYLENE INSERT CHANGE. THE PATIENT WAS SCHEDULED ON (B)(6) 2020 AND AFTER DOING OPEN SYNOVECTOMY, WE DECIDED TO CHANGE THE POLYETHYLENE INSERT FOR WHICH THE PREPARATION WAS DONE BEFOREHAND AND THE TECHNIQUE FOR REMOVAL OF THE POLYETHYLENE INSERT WAS PLANNED AS PER DISCUSSION WITH STRYKER COMPANY PERSON WERE SCRUB IN OT FROM STRYKER SIDE. WHILE TRYING TO REMOVE THE INSERT, THE POLYETHYLENE WAS FOUND TO BE TIGHTLY LOCKED WITH THE TIBIAL TRAY. AFTER A FEW TRIAL, YOUR COMPANY PERSON ADVISED TO HAMMER THE POLYETHYLENE INSERT WITH THE OSTEOTOME AND TO OUR SURPRISE, THE WHOLE TIBIAL TRAY ALONG WITH THE LOCKED POLYETHYLENE INSERT CAME OUT LEAVING THE CEMENT BASE. AS WE WERE NOT PREPARED WITH THE COMPLETE ARMAMENTARIUM, CEMENT SPACER WAS PLACED AFTER REMOVING THE CEMENT BASE LEAVING THE FEMORAL COMPONENT AND REVISION PLANNED ON A LATER DATE. WE ARE REG

  Patient problems: Injury; Synovitis

  MAUDE report 9942039 ↗
• InjurySep 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTED VIA THE WEB INTAKE PAGE: TIBIA IMPLANT SUBSITE. NOTE FROM CIC: EVENT AND RESPONSE TO THE QUESTION IS BEING CLARIFIED WITH THE SALES REP. UPDATE 09/AUGUST/2019 (B)(6): AS REPORTED IN HOW WAS ISSUE NOTICED "PATIENT WALKING IN PAIN". DEVICE DISPOSITION IS LISTED AS 'RETURN TO PATIENT' SO WAS LIKELY REVISED. UPDATE PER EMAIL RECEIVED: PATIENT FELL ON (B)(6) 2019 AND WAS REVISED ON (B)(6) 2019, LEFT SIDE.

  Patient problems: Fall; Injury; Pain

  MAUDE report 8959382 ↗