MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2016-11-07 for ZIMMER VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE LINER 00885101336 manufactured by Zimmer, Inc..
[59261546]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[59261547]
It is reported that a patient is experiencing a possible allergic reaction to implant.
Patient Sequence No: 1, Text Type: D, B5
[67678747]
No device or photos were received; therefore the condition of the device is unknown. The part and lot number of the device is unknown; therefore the device history records, complaint history could not be reviewed. The reported device is used for treatment. It could not be confirmed if the device was used in an approved and compatible combination. Surgical notes were not provided. It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. Relevant medical history and adherence to rehabilitation protocol are unknown. A definitive root cause cannot be determined with the information provided. Review of the device history records for all devices identified no deviations or anomalies. A complaint history search for part and lot combination for the continuum shell gave 8 additional complaints for the same or a similar issue. A complaint history search for part and lot combination for the bone screw gave 5 additional complaints for the same or a similar issue. A complaint history search for part and lot combination for the vit e liner gave 2 additional complaints for the same or a similar issue. A complaint history search for part and lot combination for the kinectiv m/l taper gave 19 additional complaints for the same or a similar issue. A complaint history search for part and lot combination for the kinectiv modular neck gave 7 additional complaints for the same or a similar issue. Review of the compatibility of the devices confirmed that these are an approved compatible combination. Medical records were not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001822565-2016-04098 |
| MDR Report Key | 6081201 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-11-07 |
| Date of Report | 2016-10-10 |
| Date of Event | 2015-04-08 |
| Date Mfgr Received | 2017-01-31 |
| Device Manufacturer Date | 2015-03-19 |
| Date Added to Maude | 2016-11-07 |
| 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 | PATIENT |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIMMER VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE LINER |
| Generic Name | HIP PROSTHESIS |
| Product Code | OQI |
| Date Received | 2016-11-07 |
| Catalog Number | 00885101336 |
| Lot Number | 62990604 |
| ID Number | N/A |
| 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 | 2016-11-07 |