Scorpio 82-7-0510Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327030938), received between Feb 13, 2019 and Aug 24, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2026Unstable

  The patient had an Index Left TKA on (b)(6) 2013. The patient developed instability and hyperextension, and was revised on (b)(6) 2025. All components exchanged, except the Patella.

  Patient problems: Joint Laxity

  MAUDE report 50418425 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP THAT THE PATIENT DONE THE TKR OPERATION 8 YEARS AGO. SHE WAS VERY HAPPY WITH THE OPERATION UNTIL 2 YEARS AGO SUDDENLY SWELLING AND KNEE 'JAMMED', BUT WILL FEEL BETTER AND BACK TO NORMAL AFTER A DAY OR TWO AND PERFECTLY FINE BETWEEN EPISODES. THIS YEAR IT HAPPENS MORE FREQUENTLY AND DOCTOR DECIDED TO SCHEDULE ANOTHER OPERATION TO OPEN THE KNEE AND CHANGE THE INSERT. OPERATION IS SCHEDULE TO BE ON (B)(6) 2022. (B)(6) 2022 : THE SALES REP OBSERVING THE CASE UPDATED THAT THE REVISION SCHEDULED ON (B)(6) 2022 WAS NOT PERFORMED. SURGEON'S PLAN WAS TO DO LEFT TIBIA ABSCESS DRAINAGE AND KIV CHANGE OF INSERT. DURING THE SURGERY, SURGEON DECIDED NOT TO CHANGE THE INSERT REQUIRED AS THE WOUND STILL OK. HENCE, THERE IS NO STRYKER IMPLANT WAS USED. THE REVISION WAS NOT PERFORMED.

  Patient problems: Swelling/ Edema

  MAUDE report 15454578 ↗
• InjurySep 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY SURGEON THAT INFECTION OCCURRED ON PATIENT AND REQUIRED INSERT EXCHANGE. PATIENT DID FIRST TKR 8 YEARS BACK.

  Patient problems: Unspecified Infection

  MAUDE report 12413730 ↗
• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY SALE REP THAT SURGEON INFORMED PATIENT NEED TO GO FOR CHANGE OF INSERT DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11770067 ↗
• InjuryFeb 13, 2019Mechanical Problem; Mechanical Problem

  DURING REVISION SURGERY IN (B)(6) 2019, THE POSSIBILITY THAT THE LOCKING POSTERIOR OF THE INSERT WAS OFF BY X-P WAS RECOGNIZED. ADDITIONAL INFO AT 2019/JAN/31: THE REVISION SURGERY IS PLANNED AT (B)(6) 2019/. THIS PI IS FOR THE RIGHT SIDE OF THE KNEE.

  Patient problems: Injury

  MAUDE report 8337601 ↗