MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-08-26 for PERSONA MC TIBIAL ARTICULAR SURFACE PROVISIONAL N/A 42527100710 manufactured by Zimmer Biomet, Inc..
[155700378]
(b)(4). The complaint device has been returned, but the device investigation has not yet been completed. Once the evaluation is completed, a supplemental medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[155700379]
It was reported that the device is fractured post surgery during cleaning in sterile processing department. No known adverse event was reported. Attempt for further information has been made, but no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2019-03631 |
| MDR Report Key | 8932717 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-08-26 |
| Date of Report | 2019-08-26 |
| Date of Event | 2019-07-26 |
| Date Mfgr Received | 2019-08-02 |
| Device Manufacturer Date | 2016-03-17 |
| Date Added to Maude | 2019-08-26 |
| 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 BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERSONA MC TIBIAL ARTICULAR SURFACE PROVISIONAL |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | OIY |
| Date Received | 2019-08-26 |
| Returned To Mfg | 2019-08-02 |
| Model Number | N/A |
| Catalog Number | 42527100710 |
| Lot Number | 63325844 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-26 |