Unknown stem
Received Jul 27, 2026 · Event occurred Mar 5, 2026
Report 0009613350-2026-00388 · MDR key 50039239
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Insufficient Information
Narrative
Description of Event or Problem
It was reported that the patient underwent an initial hip procedure. Subsequently, the patient underwent a revision of the shell for unspecified reasons. Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D4: Attempts have been made to gather all product identification information and no further information has been provided.D10:Therapy date: (b)(6) 2026.G2: Foreign - Event occurred in Australia.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.