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 2020-01-02 for ARTICULATION KIT SIZE 4 00-8400-094-00 00840009400 manufactured by Zimmer Biomet, Inc..
[173338898]
(b)(4). Multiple mdr's were filed in association with this reporting: 0001822565 - 2019 - 05408, 0001822565 - 2019 - 05409, 0001822565 - 2019 - 05410, 0001822565 - 2019 - 05411, 0001822565 - 2019 - 05412. Concomitant medical products: 00840001507 ulnar component plasma sprayed size 5 lot 63127158, primary di# 00889024271241, 00840004410 humeral component plasma sprayed size 4 lot 63319031, primary di# 00889024271340, 00840009000 humeral screw kit lot 63969924 primary di# 00889024271449, 32810503800 cement restrictor lot 63252559, primary di# 00889024274082. Report source: (b)(6). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[173338899]
It was reported the patient is being considered for a revision to address infection and related pain less than a year post implantation. No further information is available as the patient has not yet been revised.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2019-05411 |
| MDR Report Key | 9537501 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-02 |
| Date of Report | 2020-01-02 |
| Date Mfgr Received | 2019-12-30 |
| Device Manufacturer Date | 2018-08-28 |
| Date Added to Maude | 2020-01-02 |
| 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 | ARTICULATION KIT SIZE 4 |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | JDC |
| Date Received | 2020-01-02 |
| Model Number | 00-8400-094-00 |
| Catalog Number | 00840009400 |
| Lot Number | 64129150 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-02 |