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 2020-01-24 for HUMERAL SCREW KIT 2 HUMERAL SCREWS NI 00840009000 manufactured by Zimmer Biomet, Inc..
[176261344]
(b)(4). Concomitant medical products: humeral component size 4 cat# 00840004415 lot# 63257171, ulnar component size 4 cat# 00840002407 lot# 64083002, articulation kit size 4 cat# 00840009400 lot# 63991814. The device will not 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00272, 0001822565 - 2020 - 00274, 0001822565 - 2020 - 00275.
Patient Sequence No: 1, Text Type: N, H10
[176261345]
It was reported a patient underwent a right total elbow arthroplasty, ulnar decompression and anterior subcutaneous transposition, radial head excision. It was also reported the patient fell approximately 2 weeks later. No abnormal x-ray findings were noted at this visit. The patient had ongoing stiffness and slow progress with range of motion. Approximately 7 months after arthroplasty, a stress reaction in the medial column with minimal displacement was noted on x-ray. The patient was reportedly asymptomatic and implants were in correct placement. No revision has been reported to date. Attempts have been made and additional information on the reported event is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-00273 |
| MDR Report Key | 9627413 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-24 |
| Date of Event | 2019-07-01 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2016-05-18 |
| Date Added to Maude | 2020-01-24 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUMERAL SCREW KIT 2 HUMERAL SCREWS |
| Generic Name | PROSTHESIS, ELBOW |
| Product Code | JDC |
| Date Received | 2020-01-24 |
| Model Number | NI |
| Catalog Number | 00840009000 |
| Lot Number | 63364033 |
| 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 | 2020-01-24 |