MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-14 for UNKNOWN COONRAD-MORREY HUMERAL STEM N/A manufactured by Zimmer Biomet, Inc..
[117123672]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation at this time. Device location is unknown with limited information available and it is unknown if the patient has been revised. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-04413. Patient not yet revised.
Patient Sequence No: 1, Text Type: N, H10
[117123673]
It was reported the patient underwent initial elbow arthroplasty on an unknown date. Subsequently, patient has been indicated for an elbow revision procedure due to unknown reasons. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[134341338]
(b)(4). Reported event was unable to be confirmed due to limited information received from the customer. As per x-ray review, there is severe loosening of the humeral component of a left total elbow arthroplasty which lead to development of a fracture of the distal humeral diaphysis. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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
[134341339]
No further event information available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-04412 |
| MDR Report Key | 7783279 |
| Date Received | 2018-08-14 |
| Date of Report | 2019-01-28 |
| Date Mfgr Received | 2019-01-24 |
| Date Added to Maude | 2018-08-14 |
| 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 | 0 |
| Brand Name | UNKNOWN COONRAD-MORREY HUMERAL STEM |
| Generic Name | PROSTHESIS, ELBOW |
| Product Code | JDB |
| Date Received | 2018-08-14 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| 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 | 2018-08-14 |