UNK CUP
Received Jul 6, 2026 · Event occurred Apr 6, 2026
Report 0001822565-2026-02443 · MDR key 25716160
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Medical device site infection
Narrative
Additional Manufacturer Narrative
(B)(4). D6A: INITIAL PROCEDURES ALL BETWEEN (B)(6), 2022. D10: UNK WAGNER STEM G2: FOREIGN ¿ EVENT OCCURRED IN SPAIN G2: LITERATURE - GONZÁLEZ-ADRIO, R.L., PACHA, D., ALIAGA-MARTÍNEZ, A. ET AL. (2026). TOTAL HIP ARTHROPLASTY AS RECONSTRUCTIVE TREATMENT IN PATIENTS WITH CEREBRAL PALSY: A COMPARATIVE STUDY OF POSTOPERATIVE OUTCOMES BETWEEN PATIENTS WITH DEVELOPMENTAL HIP DYSPLASIA AND CEREBRAL PALSY HIP DYSPLASIA. EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY, 36(155). HTTPS://DOI.ORG/10.1007/S00590-026-04701-5. 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 IN A JOURNAL ARTICLE THAT ONE PATIENT EXPERIENCED AN I&D PROCEDURE FOR DEEP INFECTION ON AN UNKNOWN DATE POST-HIP SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.