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 2020-01-28 for PERSONA PARTIAL TIBIAL CEMENTED SIZE E RIGHT MEDIAL N/A 42538000502 manufactured by Zimmer Biomet, Inc..
[176632370]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product was discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Udi# (b)(4). Concomitant medical products: item # 42558000502 lot # 63466456, item # 42528200508 lot # 63449777, palacos cement item # unknown lot # unknown. Report source: (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00336, 0001822565-2020-00338.
Patient Sequence No: 1, Text Type: N, H10
[176632371]
It was reported that a study patient had a right unicompartmental knee replacement subsequently, seven months later the patient was revised and converted to a total knee due to deep infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-00337 |
| MDR Report Key | 9637944 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date of Event | 2018-05-09 |
| Date Mfgr Received | 2020-01-20 |
| Device Manufacturer Date | 2016-11-23 |
| Date Added to Maude | 2020-01-28 |
| 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 PARTIAL TIBIAL CEMENTED SIZE E RIGHT MEDIAL |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | HSX |
| Date Received | 2020-01-28 |
| Model Number | N/A |
| Catalog Number | 42538000502 |
| Lot Number | 63463512 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2020-01-28 |