MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-06-25 for CEMENTRALIZER 13.0 137622000 manufactured by Depuy Orthopaedics Inc Us.
[4651145]
Litigation alleges the patient suffers from pain, swelling, inflammation and infection. Update rec'd (b)(6) 2014 - pfs and medical records received. Part/lot information provided. A correct doi and dor was provided. After review of the medical records the patient had a poly liner implanted so the other implants besides the head and liner cannot be excluded as the cause the pain. All other implants are being added to the complaint. There is no new additional information that would affect the existing mdr decision. The complaint was updated on: (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
[12024298]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10
[21441472]
The devices associated with this report were not returned. A review of the device history records for the cc6ls4000 lot code did not reveal any related manufacturing deviations or anomalies. A complaint database search finds no other reported incidents against the remaining product and lot combinations. The investigation could not verify or identify any product contribution to the reported event with the information provided. Based on the inability to identify root cause, the need for 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 | 1818910-2014-22036 |
| MDR Report Key | 3895643 |
| Report Source | 00 |
| Date Received | 2014-06-25 |
| Date of Report | 2014-06-04 |
| Date of Event | 2014-03-10 |
| Date Mfgr Received | 2014-12-05 |
| Device Manufacturer Date | 2007-04-11 |
| Date Added to Maude | 2014-06-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVE DOWELL |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743714918 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEMENTRALIZER 13.0 |
| Generic Name | HIP OTHER IMPLANT |
| Product Code | LTO |
| Date Received | 2014-06-25 |
| Catalog Number | 137622000 |
| Lot Number | BH9DR1000 |
| Operator | PHYSICIAN |
| 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 | 2014-06-25 |