MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-08-07 for COMPREHENSIVE REVERSE GLENOSPHERE 36MM N/A 115313 manufactured by Zimmer Biomet, Inc..
[116272356]
(b)(4). Product code- phx. Concomitant medical products: xl-115364, arcom xl 44-36 std +3 hmrl brg, 990150; 115340, comp rvs hmrl ti tray 44mm, 367310; 115340 ,comp rvs hmrl ti tray 44mm, 367310; 115330, comp rvrs shdr glen bsplt +ha, 524640; 180503, comp locking screw 4. 75x30mm, 402230; 180510, comp non-lckng screw 4. 75x30mm, 448060; 115383, comp rvs cntrl scr 6. 5x35mm st, 492280; 118001, versa-dial/comp ti std taper, 201450; 180507, comp non-lckng screw 4. 75x15mm, 319810; 180501, comp locking screw 4. 75x20mm, 905410. The complaint is confirmed based on the surgical operative notes that was provided. Review of the device history records identified no related deviations or anomalies. A root cause cannot be determined based on 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 05461; 0001825034 - 2018 - 05463; 0001825034 - 2018 - 05466; 0001825034 - 2018 - 05469.
Patient Sequence No: 1, Text Type: N, H10
[116272357]
It was reported that patient experienced 750-800 ml of blood loss during the left shoulder primary surgery. The patient received a platelet gel injection at the end of the surgery. No additional patient consequences were reported. No other additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-05467 |
| MDR Report Key | 7757791 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-08-07 |
| Date of Report | 2018-08-07 |
| Date of Event | 2010-10-20 |
| Date Mfgr Received | 2018-07-12 |
| Device Manufacturer Date | 2010-05-10 |
| Date Added to Maude | 2018-08-07 |
| 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 | COMPREHENSIVE REVERSE GLENOSPHERE 36MM |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | MJT |
| Date Received | 2018-08-07 |
| Model Number | N/A |
| Catalog Number | 115313 |
| Lot Number | 302660 |
| 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. Required No Informationntervention | 2018-08-07 |