MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-18 for UNKNOWN HIP FEMORAL STEM UNK HIP FEMORAL STEM manufactured by Depuy Orthopaedics Inc Us.
[184092343]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184092344]
The literature article entitled, "total hip arthroplasty for intertrochanteric fracture fixation failure" written by liyun liu, yongqiang sun, linlin wang, qiankun gao, ang li, jialin wang and yanzheng gao published by european journal of medical research made available online 27 december 2019 was reviewed. The article's purpose is to describe total hip arthroplasty (tha) salvage treatment of elderly patient suffering intertrochanteric fracture fixation failure with positive clinical outcomes. In all cases, internal fixation was removed and then followed with procedures for tha. Acetabular cups were fixated with 2 screws and either poly or ceramic liners were utilized. The article only identifies stems utilized with 5 patients treated with non-depuy stem and 9 patients treated with depuy stem. Material of femoral head is not discussed. The article does not identify which specific products are associated with the adverse events. During discussion of patients within the study, the article reports of 2 patient deaths- one within 1 month after surgery as a result of acute pulmonary embolism and the other 6 months post surgery due to pulmonary heart disease. However, it does not identify products in these patients and it does not specify the deaths as related to the implantations. Figure 1 and figure 2 provided photographic and radiographic imaging for a 64 year old male and 71 year old male respectively. The figure descriptions suggest the images are to illustrate failed original fixations and successful thas with no related adverse events. Depuy products: solution stem. Adverse events: death from acute pulmonary embolism 1 month post surgery intraoperative femoral trochanter split (treated with steel wire and fixed with tension band) deep vein thrombosis 3 months post surgery (treated successfully).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-08450 |
| MDR Report Key | 9848332 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-13 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2020-03-18 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | JTE WARSAW MFG SITE |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN HIP FEMORAL STEM |
| Generic Name | HIP FEMORAL STEM |
| Product Code | KXA |
| Date Received | 2020-03-18 |
| Catalog Number | UNK HIP FEMORAL STEM |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-18 |