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 2020-03-30 for ULNAR COMPONENT PLASMA SPRAYED SIZE 4 115 MM LENGTH LEFT 00840001411 manufactured by Zimmer Manufacturing B.v..
[186553205]
(b)(4). Concomitant medical products: articulation kit size 4 1 axle pin, 1 humeral bearing a, 2 ulnar bearings b sterile cat: 00840009400 lot: unknown. Report source: (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up report will be submitted. Product not returned
Patient Sequence No: 1, Text Type: N, H10
[186553206]
It was reported that the patient was revised due to elbow loosening secondary to bone fracture. Attempts have been made, and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002648920-2020-00213 |
| MDR Report Key | 9899302 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-29 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-30 |
| 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 MANUFACTURING B.V. |
| Manufacturer Street | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 |
| Manufacturer City | MERCEDITA PR 00715 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00715 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULNAR COMPONENT PLASMA SPRAYED SIZE 4 115 MM LENGTH LEFT |
| Generic Name | ELBOW, PROSTHESIS |
| Product Code | JDC |
| Date Received | 2020-03-30 |
| Catalog Number | 00840001411 |
| Lot Number | 62102254 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER MANUFACTURING B.V. |
| Manufacturer Address | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 MERCEDITA PR 00715 US 00715 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-30 |