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 2018-06-21 for 2.5 MM FEMALE HEX SCREW 25 MM LENGTH N/A 42509902525 manufactured by Zimmer Biomet, Inc..
[111975539]
(b)(4). Concomitant medical products: articular surface fixed bearing posterior stabilized, p/n 42512401012, l/n 62401259; femur cemented posterior stabilized, p/n 42500607001, l/n 62330608; tibia cemented 5 degree stemmed, p/n 42532008301, l/n 62625812. (b)(6). The device will be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 03364, 3007963827 - 2018 - 00102, 0002648920 - 2018 - 00502.
Patient Sequence No: 1, Text Type: N, H10
[111975540]
It was reported the patient experienced infection approximately two months post left knee arthroplasty and was eventually revised four years post implantation after previous unsuccessful treatments. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-03383 |
| MDR Report Key | 7626785 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-21 |
| Date of Report | 2018-06-21 |
| Date of Event | 2018-05-24 |
| Date Mfgr Received | 2018-05-24 |
| Device Manufacturer Date | 2014-10-07 |
| Date Added to Maude | 2018-06-21 |
| 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 | 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 | 2.5 MM FEMALE HEX SCREW 25 MM LENGTH |
| Generic Name | PROSTHESIS KNEE |
| Product Code | HWD |
| Date Received | 2018-06-21 |
| Model Number | N/A |
| Catalog Number | 42509902525 |
| Lot Number | 62824343 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2018-06-21 |