MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-25 for SC/MSC CERAMICS INSERT 32MM 56/58 SYM. NH104 manufactured by Aesculap Implant Systems.
[106717234]
(b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[106717235]
(b)(6). Patient has felt a crack for about 4 months. At first a problem had been suspected on the knee joint. The x-ray showed that a ceramic fracture was present in the implanted hip joint. Therefore, the revision was made. Intraoperatively, the ceramic head and inlay were broken. The conus of the metha shaft was also deformed by the load, so that the shaft had to be replaced. Components in use listed as concommitant devices are: nh104 / sc/msc ceramics insert 32mm 56/58 sym. Nh058t / plasmacup sc size 58mm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00184 |
| MDR Report Key | 7463032 |
| Date Received | 2018-04-25 |
| Date of Report | 2018-04-25 |
| Date of Event | 2018-02-20 |
| Date Facility Aware | 2018-04-04 |
| Date Mfgr Received | 2018-04-03 |
| Device Manufacturer Date | 2009-04-09 |
| Date Added to Maude | 2018-04-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | AESCULAP IMPLANT SYSTEMS |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SC/MSC CERAMICS INSERT 32MM 56/58 SYM. |
| Generic Name | IMPLANTS PLASMACUP |
| Product Code | OQI |
| Date Received | 2018-04-25 |
| Returned To Mfg | 2018-04-17 |
| Model Number | NH104 |
| Catalog Number | NH104 |
| Lot Number | 51551950 |
| Device Expiration Date | 2019-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 9 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP IMPLANT SYSTEMS |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-25 |