Contour 71367156Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010451842), received between May 24, 2023 and May 24, 2023 — classified as 1 injury.

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

2 other recalls cover devices cleared under the same FDA submission (K123598); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 24, 2023Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY, THE PATIENT EXPERIENCED A PERI-PROSTHETIC FAILURE OF A STRYKER BRAND ACETABULAR CUP. THIS WAS PLANNED TO BE RESOLVED VIA A REVISION SURGERY, ON (B)(6) 2023, IN WHICH A CONTOUR RECONSTRUCTION RING WAS GOING TO BE USED TO CREATE A CAGE CUP CONSTRUCT AND SALVAGE THE JOINT. HOWEVER, DUE TO THE NATURE OF THE REMAINING BONE STOCK, A CONT RECN RING TRL 56/52 LT WOULD HAVE BEEN NEEDED TO VERIFY IF THERE WOULD HAVE BEEN ADEQUATE BONE TO SUPPORT; DURING SET UP FOR THE REVISION, THE DEVICE WAS NOT AVAILABLE, AS THIS PARTICULAR TRIAL WAS NOT SENT ALONG WITH THE IMPLANT SET OR WAS NOWHERE TO BE FOUND. AS SUCH, THE ISSUE WAS RESOLVED WITH A CHANGE IN SURGICAL TECHNIQUE (A GIRDLESTONE PROCEDURE WAS PERFORMED INSTEAD); WITHOUT ANY DELAY. PATIENT'S CURRENT HEALTH STATUS IS FINE, BUT HAS NO HIP DUE TO THE GIRDLESTONE PROCEDURE; AS SUCH, MOVEMENT IS IMPAIRED TO SOME UNKNOWN DEGREE. FOLLOW UP IS REQUIRED BUT IT WAS REPORTED THAT THE PATIENT WILL BE NEEDING A SPECIAL PROSTHESIS, NOT AVAILABLE FROM S+N. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Insufficient Information

  MAUDE report 16998341 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116