MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2020-03-24 for HEMI HEAD 46MM 74122546 manufactured by Smith & Nephew Orthopaedics Ltd.
[184809453]
It was reported that the patient underwent a revision surgery of the left hip due to metallosis, pseudotumor, extensive heterotopic ossification, osteolysis, metal-stained tissue, and brownish-black fibrous tissue as the result of premature failure of the device. The three hole hemispherical stiktite coated shell and the hemi head were explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005975929-2020-00090 |
| MDR Report Key | 9875551 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-05-24 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-24 |
| 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 | DR SARAH FREESTONE |
| Manufacturer G1 | SMITH & NEPHEW ORTHOPAEDICS LTD |
| Manufacturer Street | AURORA HOUSE SPA PARK |
| Manufacturer City | LEAMINGTON SPA CV313HL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CV31 3HL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMI HEAD 46MM |
| Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING |
| Product Code | NXT |
| Date Received | 2020-03-24 |
| Model Number | 74122546 |
| Catalog Number | 74122546 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW ORTHOPAEDICS LTD |
| Manufacturer Address | AURORA HOUSE SPA PARK LEAMINGTON SPA CV313HL UK CV31 3HL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-24 |