MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-04-05 for PREP IM ENCHANCE TOTAL HIP KIT 121010 manufactured by Smith & Nephew, Inc..
[141113218]
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Patient Sequence No: 1, Text Type: N, H10
[141113219]
It was reported that patient had a left side tha at (b)(6) public (b)(6) 2019 with a spectron/polarcup construct via a posterior approach. Patient has medical history of kidney transplant. Patient left hip wound would not heal and was infected. Patient had a washout and debridement (done by another surgeon) as well as vac dressings, prior to first stage revision on (b)(6) 2019. Dr. Performed first stage revision hip surgery on (b)(6) 2019 removing acetabular implants with zimmer explant and using renovation hip to remove femoral component. Surgeon performed an eto and removed cement from femur with renovation instruments. Acetabulum reamed and femur reamed. Wound debrided and irrigated with saline and betadine and femur cabled with circlage wire temporarily. Wound closed, and then pt re-prepped and draped with whole new setup. Pt then reopened and then dallmiles cables applied to femur and zb hip cement spacer inserted with palacos copal cement loaded with antibiotic used to fix hip cement spacer. Wound irrigated and closed in layers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2019-01400 |
| MDR Report Key | 8489189 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-05 |
| Date of Report | 2019-04-05 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-03-07 |
| Date Added to Maude | 2019-04-05 |
| 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 | PREP IM ENCHANCE TOTAL HIP KIT |
| Generic Name | CEMENT OBTURATOR |
| Product Code | LZN |
| Date Received | 2019-04-05 |
| 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 | 2019-04-05 |