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 2020-01-31 for R3 20 DEG XLPE LNR 40MM ID X 58OD 71338688 manufactured by Smith & Nephew, Inc..
[177164665]
It was reported that a revision surgery was performed due to infection. The hip was dislocated and the oxinium head was removed. The acetabulum was exposed and the liner was removed. Following this, the hip was irrigated with a zimmer antibiofilm solution for 1 liter followed by 3 liters of bacitracin in saline. All devitalized tissue and exudate were all debrided. A new liner was placed in the same position as the previous liner with anterior hood and same size head and neck, 40 mm was applied. The hip was reduced and stable with a full range of motion. Antibiotic dusting with vancomycin and tobramycin was carried out and then the surgical intervals were reapproximated with monofilament suture over 4 hemovac drains. An incisional wound vac was applied. Eight days after the revision surgery the patient developed an hematoma and it was surgically evacuated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-00423 |
| MDR Report Key | 9652866 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-31 |
| Date of Event | 2017-06-14 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2017-12-01 |
| Date Added to Maude | 2020-01-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR SARAH FREESTONE |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 0447940038 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | R3 20 DEG XLPE LNR 40MM ID X 58OD |
| Generic Name | PROSTHESIS, HIP, SEMI-CONS, UNCEMENTED, METAL/POLYMER, POROUS |
| Product Code | MBL |
| Date Received | 2020-01-31 |
| Model Number | 71338688 |
| Catalog Number | 71338688 |
| Lot Number | 17AM08509 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-01-31 |