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 2016-03-23 for CONTINUUM TRILOGY VIVACIT-E NEUTRAL LINER 00885101136 manufactured by Zimmer Inc.
[41008492]
(b)(4). Concomitant medical products: catalog #00784803300, kinectiv technology modular neck, lot #61837395; catalog #00625006530, trilogy bone screw, lot #62935932 - manufactured by zimmer (b)(4). This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[41008493]
It is reported that the patient was revised due to infection in the left hip. Screw, liner, and neck were all removed, and new ones were implanted.
Patient Sequence No: 1, Text Type: D, B5
[54903851]
The device was used for treatment. No devices were received for evaluation; therefore the condition of the devices is unknown. Device history record review identified no deviations or anomalies in the manufacturing process. The devices were used in an approved and compatible combination. Relevant medical history and adherence to rehabilitation protocol are unknown. A review of the complaint history for the part and lot combinations of the reported devices identified no additional complaints for the reported condition. Primary operative notes from the initial implant procedure and post procedure office visit notes were reviewed. Laboratory reports were not provided. The specific pathogen was not identified in the provided information. Sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards, therefore, it is highly unlikely that the specified devices caused or contributed to patient infection. A definitive root cause cannot be determined with the information provided. This is not a confirmed quality or manufacturing issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2016-00770 |
| MDR Report Key | 5520577 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-03-23 |
| Date of Report | 2016-02-25 |
| Date of Event | 2016-02-24 |
| Date Mfgr Received | 2016-08-16 |
| Device Manufacturer Date | 2015-05-13 |
| Date Added to Maude | 2016-03-23 |
| 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 | KEVIN ESCAPULE |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTINUUM TRILOGY VIVACIT-E NEUTRAL LINER |
| Generic Name | OQI |
| Product Code | OQI |
| Date Received | 2016-03-23 |
| Catalog Number | 00885101136 |
| Lot Number | 63043583 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER INC |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US 465810708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-23 |