MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-08-29 for COONRAD/MORREY TOTAL ELBOW HUMERAL COMPONENT SMALL N/A 32855510811 manufactured by Zimmer Biomet, Inc..
[118547270]
(b)(4). (b)(6). The complaint is under investigation. Once the investigation is completed a follow up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[118547271]
It was reported that the patient underwent a left elbow arthroplasty on unknown date and is now considered for a revision due to unknown reasons. No additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[134865345]
This follow-up report is being submitted to relay additional information. Implant date: unknown date, 2012 reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) was reviewed and no discrepancies were found. A definite root cause cannot be determined with the information provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[134865346]
It was reported that approximately six (6) years post implantation, the patient is experiencing pain, and is scheduled to undergo a revision. Attempts have been made and no further information has been provided at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-04597 |
| MDR Report Key | 7826276 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-08-29 |
| Date of Report | 2018-11-13 |
| Date Mfgr Received | 2018-11-13 |
| Device Manufacturer Date | 2012-07-16 |
| Date Added to Maude | 2018-08-29 |
| 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 | COONRAD/MORREY TOTAL ELBOW HUMERAL COMPONENT SMALL |
| Generic Name | PROSTHESIS, ELBOW |
| Product Code | JDB |
| Date Received | 2018-08-29 |
| Model Number | N/A |
| Catalog Number | 32855510811 |
| Lot Number | 95005060 |
| Device Expiration Date | 2017-07-31 |
| 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. Required No Informationntervention | 2018-08-29 |