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 2016-07-12 for CONTINUUM TRILOGY IT ALLOFIT VAVACIT-E HIGHLY CROSSLINKED POLY NEUTRAL LINER 00885100932 manufactured by Zimmer, Inc..
[49276997]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[49276998]
It is reported that the patient is experiencing right side groin pain.
Patient Sequence No: 1, Text Type: D, B5
[73577310]
Devices were not returned; visual and dimensional evaluations could not be performed. Review of the device history record for identified no deviations or anomalies the devices were used for treatment. The compatibility check was performed and showed that the product combination was approved by zimmer biomet. A definitive root cause cannot be determined with the information provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001822565-2016-02349 |
| MDR Report Key | 5785239 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-07-12 |
| Date of Report | 2017-04-17 |
| Date Mfgr Received | 2017-04-17 |
| Device Manufacturer Date | 2014-09-04 |
| Date Added to Maude | 2016-07-12 |
| 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 465820708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465820708 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTINUUM TRILOGY IT ALLOFIT VAVACIT-E HIGHLY CROSSLINKED POLY NEUTRAL LINER |
| Generic Name | HIP PROSTHESIS |
| Product Code | OQI |
| Date Received | 2016-07-12 |
| Catalog Number | 00885100932 |
| Lot Number | 62799446 |
| Device Expiration Date | 2019-08-31 |
| 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 | 2016-07-12 |