GAMMA 8420-2380SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327478853), received between Oct 28, 2024 and Dec 5, 2024 — classified as 3 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "STUDY: STRYKER PEGASUS SUBJECT: (B)(6): PATIENT ADMITTED TO HOSPITAL ON (B)(6) 2024 AND SEEN BY ORTHOPEDICS FOR 3 CM AREA OF DEHISCENCE OF SUPEROLATERAL ASPECT OF RIGHT KNEE. THIS WAS IRRIGATED AND CLOSED BEDSIDE WITH NYLON SUTURES AND LATER WRAPPED WITH COMPRESSION DRESSING, THEN SOFT."

  Patient problems: Wound Dehiscence

  MAUDE report 20855075 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "STUDY: STRYKER PEGASUS SUBJECT: (B)(6). HYPERKALEMIA/ACUTE RENAL FAILURE WITH ELEVATED LIVER ENZYMES, CAUSING UREMIA AND ENCEPHALOPATHY. PATIENT RETURNED TO HOSPITAL APPROXIMATELY ONE MONTH AFTER ORTHOPAEDIC REOPERATION WITH ACUTE RENAL FAILURE PRESENTING WITH CONFUSION, POSSIBLY DUE TO COMBINATION OF REOPERATION/ANTIBIOTICS AND UNDERLYING COMORBIDITIES (METASTATIC CANCER)."

  Patient problems: Renal Impairment

  MAUDE report 20854361 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: STUDY: STRYKER PEGASUS SUBJECT: (B)(6). X-RAYS TAKEN ON (B)(6) 2024 SHOW ANTERIOR DISPLACEMENT OF THE DISTAL FEMORAL ROD WITH SUGGESTS PROXIMAL OSSEOUS COLLAPSE DUE TO TUMOR BURDEN. OPEN REDUCTION INTERNAL FIXATION WITH LATERAL PLATE AND SCREWS OVERLAPPING THE GAMMA 4 IMPLANT."

  Patient problems: Bone Fracture(s)

  MAUDE report 20543332 ↗