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 2018-08-31 for COMPREHENSIVE REVERSE GLENOSPHERE 36MM +3MM OFFSET N/A 115313 manufactured by Zimmer Biomet, Inc..
[118914187]
(b)(4). Additional concomitant medical products: 115370 comp rvs tray co 44mm 652170; 115330 comp rvrs shdr glen bsplt +ha 786790; 118001 versa-dial/comp ti std taper 352400; xl-115363 arcom xl 44-36 std hmrl brng 285250; 113636 comp primary stem 16mm mini 614090; 115396 comp rvs cntrl 6. 5x30mm st/rst 331330; 180554 comp lk scr 3. 5hex 4. 75x35 st 602980; 180550 comp lk scr 3. 5hex 4. 75x15 st 410190; 180550 comp lk scr 3. 5hex 4. 75x15 st 610760. The investigation is in progress. A follow up report will be submitted once the investigation is completed. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08639.
Patient Sequence No: 1, Text Type: N, H10
[118914188]
It was reported that the patient had difficulty in urinating after closed reduction of a reverse total shoulder prosthesis was performed. Patient? Had a lot of visits to the er? For in and out catheters, and subsequently developed a uti. Patient was referred to a urologist and prescribed medication for treatment. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-08640 |
| MDR Report Key | 7837455 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-08-31 |
| Date of Report | 2018-10-03 |
| Date of Event | 2018-05-31 |
| Date Mfgr Received | 2018-09-05 |
| Device Manufacturer Date | 2017-09-22 |
| Date Added to Maude | 2018-08-31 |
| 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 +3MM OFFSET |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | PAO |
| Date Received | 2018-08-31 |
| Model Number | N/A |
| Catalog Number | 115313 |
| Lot Number | 142560 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-08-31 |