MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-03-10 for UNKNOWN HIP FEMORAL HEAD UNK HIP FEMORAL HEAD manufactured by Depuy Orthopaedics Inc Us.
[188472569]
(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
[188472570]
The literature article entitled, "primary total hip arthroplasty for charcot arthropathy is associated with high complications but improved clinical outcomes" written by brian p. Chalmers, md, meagan e. Tibbo, md, robert t. Trousdale, md, david g. Lewallen, md, daniel j. Berry, md, and matthew p. Abdel, md published by the journal of arthroplasty made available online 10 april 2018 was reviewed. The article's purpose: "the goal of this study was to analyze the outcomes of tha for end-stage charcot arthropathy at a single institution with specific focus on (1) survivorship free of revision or reoperation, (2) complications, (3) clinical outcomes, and (4) radiographic outcomes. " data was compiled from 11 patients and 12 thas (age range 31-79 years receiving implantations between january 1, 2007 and december 31, 2014. It is noted depuy products were utilized in conjunction with non-depuy products with only 1 acetabular component identified as depuy (pinnacle) and depuy femoral components consisted of 5 aml stems, 2 summit stems and 1 srom stem leaving the 4 remaining as non-depuy stems. Bearing surface materials are unknown. The article reports all acetabular components were uncemented and fixated with 2 screws and all but 1 non-depuy stem were uncemented. The article provides a table (table 1) with patient identifiers but fails to assign products to each patient and therefore specific adverse events cannot be associated with specific products. The article provides radiographic imaging for pre-operative conditions without implantations for figures 2-4 and provides radiographic imaging of unidentified hip implant in figure 1b and 1c with preoperative image in figure 1a of the 45 year old male patient. The figure note gives no indication of any adverse events and describes the following in the figure 1 note: "he underwent a tha with a tantalum acetabular cup, a tantalum augment, and supplemental screw fixation for a paprosky type 3a acetabular bone defect and a fully coated femoral stem as noted in the ap hip (b) and cross-table lateral (c) radiographs. " depuy products: pinnacle cup, summit stem, aml stem, srom stem, unknown femoral head, unknown liner narrative description adverse events without identified products: dislocations (treated by closed reduction and/or revision) superficial wound infected (treated by antibiotics) intraoperative femoral fracture (treated by cerclage cable).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-07388 |
| MDR Report Key | 9813709 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-02 |
| Date of Event | 2018-04-10 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-10 |
| 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 HEAD |
| Generic Name | HIP FEMORAL HEAD |
| Product Code | KXA |
| Date Received | 2020-03-10 |
| Catalog Number | UNK HIP FEMORAL HEAD |
| 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 | 2020-03-10 |