RINGLOC HIP SYSTEM
Received May 20, 2026 · Event occurred Sep 28, 2012
Report 0001825034-2026-01415 · MDR key 25237106
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Abscess
- Bacterial Infection
- Pain
- Medical device site infection
Narrative
Additional Manufacturer Narrative
(B)(4). D10: CAT#: 14-103205, LOT#: 608030 TAPERLOC MICROP FMRL 11.0MM. G2: FOREIGN ¿ EVENT OCCURRED IN CANADA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-HI PREVISION, THE PATIENT UNDERWENT A HIP I&D AND TWO STAGE REVISION FOR A LEFT HIP ABSCESS. THE PATIENT PRESENTED TO THE HOSPITAL WITH AN ABSCESS, WARMTH, AND PAIN. AN I&D WAS PERFORMED WITH A DRAIN PLACED. THE NEXT DAY, THE PATIENT UNDERWENT A STAGE ONE REVISION FOR INFECTION. THE CUP, HEAD, AND LINER WERE EXCHANGED WITH CEMENT SPACERS IMPLANTED AND THE STEM RETAINED. THE SECOND STAGE REVISION WAS PERFORMED ON AN UNKNOWN DATE WITH UNKNOWN PRODUCT IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.