MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-12-21 for CEMENTRALIZER 12.0 137621000 manufactured by Depuy Orthopaedics Inc Us.
[63056608]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[63056609]
Litigation alleges patient was revised to address pain, elevated ions, discomfort and loosening. Update 12/09/2016? Pfs and medical records received. After review of the medical records for mdr reportability, after review of the medical records for mdr reportability, the patient first revised on (b)(6) 2010 (b)(4) for loose stem and dislocation. She was revised a second time on (b)(6) 2010 for dislocation (b)(4). She was revised a third time on (b)(6) 2016 for loose stem with subsidence, infection, and pain. All implants were revised for the infection and spacers were placed. Infection is alleged per litigation. The cup, cementralizer, and hole eliminator are being added to the complaint for the infection since it was alleged. The part/lot is being changed for the stem as the wrong stem was previously reported. No labs were provided for the alleged high metal ion levels. Competitor cement was used. The complaint was updated on: 12/21/2016.
Patient Sequence No: 1, Text Type: D, B5
[65042790]
No device associated with this report was received for examination. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. 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 | 1818910-2016-33839 |
| MDR Report Key | 6195968 |
| Report Source | CONSUMER |
| Date Received | 2016-12-21 |
| Date of Report | 2016-12-09 |
| Date of Event | 2016-03-15 |
| Date Mfgr Received | 2017-01-11 |
| Device Manufacturer Date | 2010-06-25 |
| Date Added to Maude | 2016-12-21 |
| 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 | ATTORNEY |
| 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. |
| 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 12.0 |
| Generic Name | HIP OTHER IMPLANT |
| Product Code | LTO |
| Date Received | 2016-12-21 |
| Catalog Number | 137621000 |
| Lot Number | EY6RC1000 |
| 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 | 2016-12-21 |