MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-12-07 for CONTINUUM, TRILOGY IT, ALLOFIT IT LONGEVITY POLY LINER N/A 00875101136 manufactured by Zimmer Manufacturing B.v..
[61659132]
Concomitant medical products: item #: 00811400100, femoral stem, lot #: 63235991, (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[61659133]
It is reported that the patient was revised 6 months after implantation due to dislocation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002648920-2016-04371 |
| MDR Report Key | 6152273 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-12-07 |
| Date of Report | 2017-10-01 |
| Date of Event | 2016-11-04 |
| Date Mfgr Received | 2017-09-30 |
| Device Manufacturer Date | 2016-02-16 |
| Date Added to Maude | 2016-12-07 |
| 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 |
| 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 MANUFACTURING B.V. |
| Manufacturer Street | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 |
| Manufacturer City | MERCEDITA PR 00715 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00715 |
| 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 IT LONGEVITY POLY LINER |
| Generic Name | PROSTHESIS, HIP |
| Product Code | OQI |
| Date Received | 2016-12-07 |
| Model Number | N/A |
| Catalog Number | 00875101136 |
| Lot Number | 63254478 |
| ID Number | SEE H10 |
| 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 MANUFACTURING B.V. |
| Manufacturer Address | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 MERCEDITA PR 00715 US 00715 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-12-07 |