PLASMACUP SC SIZE 50MM
Received Dec 14, 2022 · Event occurred Dec 6, 2022
Report 9610612-2022-00373 · MDR key 15979540
Device
Generic name
Hip Endoprosthetics
Manufacturer
Aesculap AgModel number
NH050TCatalog number
NH050T
Lot number
51676348
Product problems
- Fracture
- Fracture
Patient
Unknown
- Failure of Implant
- Failure of Implant
Narrative
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NH050T - PLASMACUP SC SIZE 50MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PRODUCT BROKE DURING SURGERY. IN THE X-RAY IMAGE, THE ANTEVERSION OF THE CUP WAS NOT SEEN, AND IT WAS RATHER BACKWARD. THE DISLOCATION RESISTANCE WAS IMPROVED BY CHANGING THE HEAD SIZE FROM M TO XL. A REVISION SURGERY WAS NECESSARY. THE INITIAL PROCEDURE HAD BEEN TOTAL HIP ARTHROPLASTY (THA); AND IT WAS NOTED THAT THE PATIENT EXPERIENCED DISLOCATION MANY TIMES. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE: (B)(4). INVOLVED COMPONENTS NJ211T - BICONTACT D PLASMAPORE 8/10 SIZE 11MM - LOT: 51664088, NJ107 - BIOLOX PROSTHESIS HEAD 8/10 32MM M - LOT: 51705304, NH102 - SC/MSC CERAMICS INSERT 32MM 48 - 51708119.