MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-02-08 for CEMENTRALIZER 14.0 137636000 manufactured by Depuy Orthopaedics, Inc. 1818910.
[37679202]
Additional narrative: this complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. 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
[37679203]
Patient was revised to address pain and femoral stem loosening. Loosening was noted to be at the cement to bone interface. Depuy cement was used. Update rec'd 01/14/2016 - the patient's medical records were received. Medical records were reviewed for mdr reportability. According to the medical records, during implantation, a fracture line along the posterior aspect of the greater trochanter extending in a triangular manner to the lateral aspect of the shaft was noticed after broaching. To prevent propagation of the fracture line, a cable was placed along the distal aspect of the fracture. Also noted in the medical records, the patient lost 1100ml of blood. At this time all depuy components are being reported and the part/lot information for the cement is being updated, as it is unknown what the cause of the extensive blood loss. The complaint was updated on: 02/02/2016.
Patient Sequence No: 1, Text Type: D, B5
[39943752]
No device associated with this report was received for examination. A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution. 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. Corrective action was not indicated. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
[40748627]
Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
[40748628]
Update rec'd 02/16/2016 - the patient's medical records were received. Medical records were reviewed for mdr reportability. According to the medical records upon revision the acetabular liner showed mild wear. At this time there is no new information that would change the existing mdr decision. The complaint was updated on: 03/17/2016.
Patient Sequence No: 1, Text Type: D, B5
[45238641]
No device associated with this report was received for examination. A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution. 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. Corrective action was not indicated. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2016-12899 |
| MDR Report Key | 5417061 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-02-08 |
| Date of Report | 2016-01-14 |
| Date of Event | 2016-01-05 |
| Date Mfgr Received | 2016-05-11 |
| Device Manufacturer Date | 2010-04-09 |
| Date Added to Maude | 2016-02-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| 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 | CEMENTRALIZER 14.0 |
| Generic Name | HIP OTHER IMPLANT |
| Product Code | LTO |
| Date Received | 2016-02-08 |
| Catalog Number | 137636000 |
| Lot Number | EN1K21000 |
| Device Expiration Date | 2015-04-08 |
| 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. 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-02-08 |