BIO-PREP BONE PREPARATION KIT
Received Jan 21, 2025 · Event occurred Dec 31, 2024
Report 3015967359-2025-00141 · MDR key 21200839
Device
Generic name
Prosthesis, Hip, Cement Restrictor
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
0206710000
Lot number
VMSR
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. SUPPLEMENTAL RATIONALE. CORRECTED DATA: H6, H11. 1 PREVIOUSLY REPORTED EVENT IS INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS: 1 DEVICE WAS RECEIVED.
Description of Event or Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.
Additional Manufacturer Narrative
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS 1 EVENT WAS REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. ADDITIONAL INFORMATION 1 DEVICE WAS LABELED FOR SINGLE-USE. 1 DEVICE WAS NOT REPROCESSED OR REUSED.
Description of Event or Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.