MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-04-01 for COMPR 12MM IM HMRL N/A CP562390 manufactured by Zimmer Biomet, Inc..
[140592084]
(b)(4). Product code- mbf. Udi: (b)(4). 510k a similar device is cleared under k060692. Concomitant medical products: cp562391 disc lt dstl hmrl bdy set 050970; unknown discovery ulna; unknown articulation kit. The complaint is under investigation. Once the investigation is completed, a follow up report will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2019 -01390.
Patient Sequence No: 1, Text Type: N, H10
[140592085]
It was reported that the patient underwent a total humeral/distal humeral replacement. Subsequently, the patient is being considered for a revision due to disassociation of the linkage between the distal humeral and total humeral components. No additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-01387 |
| MDR Report Key | 8471385 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-04-01 |
| Date of Report | 2019-05-21 |
| Date Mfgr Received | 2019-05-01 |
| Device Manufacturer Date | 2016-11-16 |
| Date Added to Maude | 2019-04-01 |
| 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 | COMPR 12MM IM HMRL |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | MBF |
| Date Received | 2019-04-01 |
| Model Number | N/A |
| Catalog Number | CP562390 |
| Lot Number | 047750 |
| 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 | 2019-04-01 |