MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-08-02 for UNKNOWN HUMERAL BEARING N/A manufactured by Zimmer Biomet, Inc..
[115830278]
(b)(4). Concomitant medical products: unknown, humeral stem, unknown humeral tray, unknown glenoid. Unknown glenoid base plate. Dave r shukla, julia lee, devin mangold, robert h cofield, joaquin sanchez-sotelo, & john w sperling, (2018). Reverse shoulder arthroplasty with proximal humeral replacement for the management of massive proximal humeral bone loss. Journal of shoulder and elbow arthroplasty, volume 2: pg. 1? 6. Doi: 10. 1177/2471549218779845, journals. Sagepub. Com/home/sea. Reported event was unable to be confirmed. Dhr review was unable to be performed as the item and lot number of the device involved in the event is unknown. Root cause could not 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
[115830279]
It was reported in the journal article that scapular notching was noted in 3 patients: grade 2 in 2 patients and grade 3 in 1 patient. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-05407 |
| MDR Report Key | 7743386 |
| Report Source | LITERATURE |
| Date Received | 2018-08-02 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-04-04 |
| Date Mfgr Received | 2018-10-02 |
| Date Added to Maude | 2018-08-02 |
| 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 | UNKNOWN HUMERAL BEARING |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | MJT |
| Date Received | 2018-08-02 |
| 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. Other | 2018-08-02 |