MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-12-23 for REFOBACIN BONE CEMENT R 1X40G 3003940001 manufactured by Biomet France S.a.r.l..
[177941122]
(b)(4). Report source, foreign, event occurred in (b)(6). The device was not returned to the manufacturer. Therefore it could not be analyzed. The review of the device manufacturing quality record indicate that 2. 615 products designation refobacin bone cement r 40x1, reference (b)(4), batch a750cd0910 were manufactured on (july 16, 2018). The device manufacturing quality record ((b)(4)) indicates that the released product met all requirements to perform as intended. No non conformity or deviation was observed which could be linked to the complaint issue (complaint category inner sterile pouch open sealing) event described in the complaint. The device manufacturing quality record indicates that the released product met all requirements to perform as intended. According to available data, the most probable root cause is due to packaging issue (sealing process). Corrective action has been initiated to address reported issue. 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
[177941123]
It is found that the inner sterile packaging is opened during the surgery. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2019-00554 |
| MDR Report Key | 9509160 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-12-23 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-12-04 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2018-07-16 |
| Date Added to Maude | 2019-12-23 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFOBACIN BONE CEMENT R 1X40G |
| Generic Name | BONE CEMENT, ANTIBIOTIC |
| Product Code | MBB |
| Date Received | 2019-12-23 |
| Catalog Number | 3003940001 |
| Lot Number | A750CD0910 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-12-23 |