MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-31 for PREP IM ENCHANCE TOTAL HIP KIT 121010 manufactured by Smith & Nephew, Inc..
[140422246]
Patient Sequence No: 1, Text Type: N, H10
[140422247]
It was reported that a revision surgery was performed due to infection. Primary surgery was performed on (b)(6) 2019. Patient left hip wound would not heal and was infected. Patient had a washout and debridement prior to first stage revision on (b)(6) 2019, acetabular implants and femoral component were removed. Antibiotic cement spacer implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2019-01270 |
| MDR Report Key | 8468041 |
| Date Received | 2019-03-31 |
| Date of Report | 2019-06-26 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-03-07 |
| Date Added to Maude | 2019-03-31 |
| 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 | 0 |
| Brand Name | PREP IM ENCHANCE TOTAL HIP KIT |
| Generic Name | CEMENT OBTURATOR |
| Product Code | LZN |
| Date Received | 2019-03-31 |
| Catalog Number | 121010 |
| Lot Number | 18GSM0212 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-03-31 |