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 2020-03-13 for PROTRUSIO CAGE 52OD X 49ID R 1011-71-000 101171000 manufactured by Depuy Orthopaedics Inc Us.
[188225358]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. No device associated with this report was received for examination. Review of the attached image found the device to be fractured. The root cause of the fracture could not be determined. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188225359]
The literature article entitled, "the evolution of the cup-cage technique for major acetabular defects full and half cup-cage reconstruction" written by peter k. Sculco, md, cameron k. Ledford, md, arlen d. Hanssen, md, matthew p. Abdel, md and david g. Lewallen, md published by the journal of bone and joint surgery 2017 was reviewed. The article's purpose was to report on the results of utilizing cup-cage technique for major acetabular defects. Non-depuy acetabular shells were used in conjunction with depuy protrusio cages and non depuy joint reconstruction cages. Data was compiled from 57 cases. Table iii provides patient identifiers and adverse events but not identify if products involved were depuy or non depuy. Depuy product: protrusio cage. Adverse events: sciatic nerve injury (treated by reoperation) hematoma (treated by opeartive evacuation) cage/cup construct loosening (treated by revision - see figure 5a-5b) recurrent instability accompanied by dislocation (treated by revision).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-07901 |
| MDR Report Key | 9832126 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-11 |
| Date of Event | 2017-01-01 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2008-10-29 |
| Date Added to Maude | 2020-03-13 |
| 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 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTRUSIO CAGE 52OD X 49ID R |
| Generic Name | MISCELLANEOUS JOINT IMPLANTS : HIP ACETABULAR CAGES |
| Product Code | JDJ |
| Date Received | 2020-03-13 |
| Model Number | 1011-71-000 |
| Catalog Number | 101171000 |
| Lot Number | C5GBC1000 |
| Device Expiration Date | 2018-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-13 |