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 2018-08-06 for COMPREHENSIVE REVERSE E1 HUMERAL BEARING N/A EP-115393 manufactured by Zimmer Biomet, Inc..
[116209514]
(b)(4). Concomitant medical products: 115310, comp rvrs shldr glnsp std 36mm 129260; 113629, comp primary stem 9mm mini, 979660; 115370, comp rvs tray co 44mm, 596600; 010000589, comp rvrs 25mm bsplt ha+adptr, 592930;? 180558, comp nlk scr 3. 5hex 4. 75x20 st, 860890; 180560, comp nlk scr 3. 5hex 4. 75x30 st, 018440; 115397, comp rvs cntrl 6. 5x35mm st/rst, 569900. The investigation is in progress. Once the investigation is completed a follow up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2018 -06009; 0001825034 -2018 -06014; 0001825034 -2018 -06025; 0001825034 -2018 -06029.
Patient Sequence No: 1, Text Type: N, H10
[116209515]
It was reported that the patient underwent a reverse total shoulder arthroplasty, and was revised due to unknown reasons approximately five (5) months post-implantation. No additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-06031 |
| MDR Report Key | 7754454 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-08-06 |
| Date of Report | 2019-01-10 |
| Date of Event | 2018-02-28 |
| Date Mfgr Received | 2019-01-09 |
| Device Manufacturer Date | 2017-08-21 |
| Date Added to Maude | 2018-08-06 |
| 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 E1 HUMERAL BEARING |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | PAO |
| Date Received | 2018-08-06 |
| Model Number | N/A |
| Catalog Number | EP-115393 |
| Lot Number | 734030 |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-08-06 |