MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-21 for NOT COMMUNICATED manufactured by Biomet France S.a.r.l..
[137316392]
(b)(4). (b)(6). The device was not evaluated as the batch number was not communicated and the product was not returned. The device will not returned to the manufacturer. Therefore it could not be analyzed. The device manufacturing quality record could not be reviewed as the item and lot number of the product were not communicated. With the available information, the exact root cause of the event could not be determined. 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
[137316393]
It has been reported that the monomer was not entering into the cement system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2019-00109 |
| MDR Report Key | 8357541 |
| Date Received | 2019-02-21 |
| Date of Report | 2019-08-29 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2019-08-28 |
| Device Manufacturer Date | 2017-12-27 |
| Date Added to Maude | 2019-02-21 |
| 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 | BIOMET FRANCE S.A.R.L. |
| Manufacturer Street | PLATEAU DE LAUTAGNE BP75 |
| Manufacturer City | VALENCE CEDEX 26903 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 26903 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NOT COMMUNICATED |
| Generic Name | NOT COMMUNICATED |
| Product Code | JDY |
| Date Received | 2019-02-21 |
| Catalog Number | NOT COMMUNICATED |
| Lot Number | NOT COMMUNICATED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET FRANCE S.A.R.L. |
| Manufacturer Address | PLATEAU DE LAUTAGNE BP75 VALENCE CEDEX 26903 FR 26903 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-21 |