MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-24 for EXPLOR 8X28MM IMPL STEM W/SCR N/A 11-210063 manufactured by Zimmer Biomet, Inc..
[184658308]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device evaluated by manufacturer? Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[184658309]
It has been reported that during an initial elbow procedure size seven (7) mm stem was missing and the representative told the surgeon about the missing implant. The surgeon ended up implanting an eight (8)mm stem and it was proud and he cracked the cortex. No additional information is available at this moment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-01169 |
| MDR Report Key | 9871893 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-03-01 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-10-30 |
| Date Added to Maude | 2020-03-24 |
| 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 | EXPLOR 8X28MM IMPL STEM W/SCR |
| Generic Name | PROSTHESIS ELBOW |
| Product Code | KWI |
| Date Received | 2020-03-24 |
| Model Number | N/A |
| Catalog Number | 11-210063 |
| Lot Number | 265640 |
| 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. Other | 2020-03-24 |