MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-24 for CONTROL CABLE W/CABLE SLEEVE 1739-28-000 173928000 manufactured by Depuy Orthopaedics Inc Us.
[189003577]
(b)(4). Initial reporter occupation: lawyer. 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. 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.
Patient Sequence No: 1, Text Type: N, H10
[189003578]
Litigation papers allege the patient suffered pain and excessive chromium and cobalt blood levels. Update rec'd 03/31/2015 - plaintiff? S preliminary disclosure form was received, which identified part/lot information. The complaint and associated mdrs were updated. There was no new information that would change the outcome of the investigation. The complaint was updated on: 4/15/15. Update ad 31 dec 2019: (b)(4) has been re-opened under (b)(4) due to asr medical records received. After review of medical records the patient was revised to address mom reaction with formation of large pseudo-cyst resulting to pain and swelling. Operative note reported leg length discrepancy, pseudo-cyst was noted, fluid was slightly orange tinged but clear. A lot of fibrinous and tan colored debris collected. Minimal corrosion of the trunion. One of the cable was loose and was removed. There was large osteophyte posterior aspect of the acetabulum. Added revision date, srom stem due to mild corrosion. A depuy cable was reported since it was loose, revision surgeon name, medical history and age of the patient. Corrected patient identifier doi: (b)(6) 2007; dor: (b)(6) 2016 (left hip).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-02795 |
| MDR Report Key | 9627490 |
| Report Source | OTHER |
| Date Received | 2020-01-24 |
| Date of Report | 2012-11-02 |
| Date Mfgr Received | 2020-01-10 |
| Device Manufacturer Date | 2007-07-16 |
| Date Added to Maude | 2020-01-24 |
| 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 | 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 | CONTROL CABLE W/CABLE SLEEVE |
| Generic Name | HIP MISCELLANEOUS : CABLE/WIRE |
| Product Code | JDQ |
| Date Received | 2020-01-24 |
| Model Number | 1739-28-000 |
| Catalog Number | 173928000 |
| Lot Number | B1WBG1000 |
| 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 | 2020-01-24 |