MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2019-03-18 for CUSTOM LT IBP MED HUMERAL COMP N/A CP560539 manufactured by Zimmer Biomet, Inc..
[139092206]
(b)(4). Concomitant medical products: 114368 ibp ulna left std intlk 221552. The complaint is under investigation. Once the investigation is completed a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[139092207]
It was reported that the patient underwent an initial left elbow arthroplasty and subsequently was revised due to unknown reasons approximately ten (10) years post-implantation. No additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-01117 |
| MDR Report Key | 8429227 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2019-03-18 |
| Date of Report | 2019-06-14 |
| Date of Event | 2012-05-16 |
| Date Mfgr Received | 2019-06-10 |
| Device Manufacturer Date | 2002-07-01 |
| Date Added to Maude | 2019-03-18 |
| 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 | CUSTOM LT IBP MED HUMERAL COMP |
| Generic Name | PROSTHESIS, ELBOW |
| Product Code | JDB |
| Date Received | 2019-03-18 |
| Model Number | N/A |
| Catalog Number | CP560539 |
| Lot Number | 750420 |
| Device Expiration Date | 2012-07-31 |
| 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. Hospitalization; 2. Required No Informationntervention | 2019-03-18 |