MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-10-06 for CONTINUUM, ALLOFIT IT, TRILOGY IT VIVACIT-E POLY LINER N/A 00885101136 manufactured by Zimmer, Inc..
[56597509]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[56597510]
It is reported that the patient was experiencing pain.
Patient Sequence No: 1, Text Type: D, B5
[75371550]
This follow-up report is being submitted to relay corrected and additional information. Device was not returned for analysis; therefore, a product evaluation could not be conducted. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no were trends identified. Root cause was undetermined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[75371551]
It was reported that the patient experienced pain approximately 2 years post-implantation. It was further reported that the pain resolved with over-the-counter pain relievers, ice and heat treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2016-03605 |
| MDR Report Key | 6004127 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-10-06 |
| Date of Report | 2017-05-11 |
| Date of Event | 2016-08-22 |
| Date Mfgr Received | 2017-05-11 |
| Device Manufacturer Date | 2014-02-24 |
| Date Added to Maude | 2016-10-06 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER, INC. |
| Manufacturer Street | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46580 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTINUUM, ALLOFIT IT, TRILOGY IT VIVACIT-E POLY LINER |
| Generic Name | HIP PROSTHESIS |
| Product Code | OQI |
| Date Received | 2016-10-06 |
| Model Number | N/A |
| Catalog Number | 00885101136 |
| Lot Number | 62602465 |
| ID Number | NI |
| Device Expiration Date | 2019-01-31 |
| 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 | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-06 |