MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-01-31 for E1 44-41 STD HMRL BRNG EP-115396 manufactured by Zimmer Biomet, Inc..
[134595146]
(b)(4). Concomitant medical products: 115320, comp rvrs shldr glnsp std 41mm, 982860. 110032410, comp aug mini bsplt w tpr sm, 64027393. 115370, comp rvs tray co 44mm, 430240. 113631, comp primary stem 11mm mini, 429670. 180553, comp lk scr 3. 5hex 4. 75x30 st, 641770. 180553, comp lk scr 3. 5hex 4. 75x30 st, 237980. 180551, comp lk scr 3. 5hex 4. 75x20 st, 482230. 180550, comp lk scr 3. 5hex 4. 75x15 st, 777050. 115395, comp rvs cntrl 6. 5x25mm st/rst, 837870. Report source: foreign- (b)(6). 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: 0001825034-2019-00213, 0001825034-2019-00214, 0001825034-2019-00215.
Patient Sequence No: 1, Text Type: N, H10
[134595147]
It was reported that the patient underwent an initial reverse shoulder arthroplasty and underwent a revision due to hematoma approximately one month post implantation. No additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-00405 |
| MDR Report Key | 8292709 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-01-31 |
| Date of Report | 2019-03-12 |
| Date of Event | 2018-12-29 |
| Date Mfgr Received | 2019-03-11 |
| Device Manufacturer Date | 2018-08-09 |
| Date Added to Maude | 2019-01-31 |
| 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 | E1 44-41 STD HMRL BRNG |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | PAO |
| Date Received | 2019-01-31 |
| Catalog Number | EP-115396 |
| Lot Number | 512120 |
| 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 | 2019-01-31 |