ATTUNE 1517-10-908Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295056355), received between Jul 13, 2020 and Dec 6, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 16, 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.

• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS LINKED TO (B)(4) WHICH REPORTED ON THE NON-DEPUY PRIMARY SURGERY. PATIENT UNDERWENT REVISION KNEE SURGERY ON (B)(6) 2020 WHERE AN ATTUNE REVISION SYSTEM WAS UTILISED (DR (B)(6), (B)(6) HOSPITAL). DEPUY CEMENT NOT UTILISED. PATIENT INITIALLY DID WELL BUT OVER TIME HAS HAD PROGRESSIVE RESTRICTION TO RANGE OF MOTION. PATIENT HAS PRESENTED WITH A STIFF KNEE. APPROXIMATELY 25 DEGREES OF EXTENSION TO 80 DEGREES FLEXION A DECISION WAS MADE TO OPEN THE KNEE, REMOVE AS MUCH SCAR TISSUE AS POSSIBLE AND EXCHANGE THE 8MM POLY INSERT TO A 6MM POLY INSERT. ALL COMPONENTS WERE WELL FIXED THE RANGE OF MOTION WAS IMPROVED TO APPROXIMATELY 5 DEGREES TO 110 DEGREES. DOI: UNKNOWN (NON-DEPUY PRODUCTS). DOR (1ST): (B)(6) 2020. DOR (2ND): (B)(6) 2021.

  Patient problems: Muscular Rigidity

  MAUDE report 12933447 ↗
• MalfunctionJul 13, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT PRIMARY TKA WITH REVISION PARTS. AT TIME OF POLY INSERTION, EXTREME DIFFICULTY WAS HAD REDUCING THE POLY & FEMORAL INTERFACE. MANY ATTEMPTS WERE MADE TO REDUCE CONSTRUCT. THERE WAS A SURGICAL DELAY OF 20 MINS. DOE: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10264294 ↗