MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-14 for E1 44-41 STD +3 HMRL BRG N/A EP-115397 manufactured by Zimmer Biomet, Inc..
[138827268]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Unique identifier (udi) #: n/a. Concomitant medical products: pm555222, herbert pm compr rvs ha bp, lot: 728920; 118001, versa-dial/comp ti std taper, lot: 194470; 113648, comp primary stem 8mm std, lot: 864660; 115323, comp rvsr shldr glnsp +3 41mm, lot: 788010; 115370, comp rvs tray co 44mm, lot: 448500; 115386, comp rvs cntrl scr 6. 5x50mm st, lot: 269000; 180554, comp lk scr 3. 5hex 4. 75x35 st, lot: 729380; 180554, comp lk scr 3. 5hex 4. 75x35 st, lot: 932440; 180552, comp lk scr 3. 5hex 4. 75x25 st, lot: 376810; 180556, comp lk scr 3. 5hex 4. 75x45 st, lot: 620150. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 01170, 0001825034 - 2019 - 01171, 0001825034 - 2019 - 01172, 0001825034 - 2019 - 01173, 0001825034 - 2019 - 01174.
Patient Sequence No: 1, Text Type: N, H10
[138827269]
It was reported that approximately 5 years post implantation, the patient has been indicated for a shoulder revision due to unknown reasons. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-01176 |
| MDR Report Key | 8421755 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-14 |
| Date of Report | 2019-06-11 |
| Date of Event | 2014-04-24 |
| Date Mfgr Received | 2019-05-29 |
| Device Manufacturer Date | 2013-04-30 |
| Date Added to Maude | 2019-03-14 |
| 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 | . |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E1 44-41 STD +3 HMRL BRG |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | PAO |
| Date Received | 2019-03-14 |
| Model Number | N/A |
| Catalog Number | EP-115397 |
| Lot Number | 230960 |
| Device Expiration Date | 2018-04-30 |
| 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. Hospitalization; 2. Required No Informationntervention | 2019-03-14 |