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 2018-10-15 for E1 44-36 STD HMRL BRNG N/A EP-115393 manufactured by Zimmer Biomet, Inc..
[123748298]
(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. (b)(4). Concomitant medical products: 010000589, comp rvrs 25mm bsplt ha+adptr, 163320; 110004347, sig glen ct gd/bone model set, 474650; 113615, comp primary stem 15mm micro, 595350; 115310, comp rvrs shldr glnsp std 36mm, 837030; 115370, comp rvs tray co 44mm, 397550; 115395, comp rvs cntrl 6. 5x25mm st/rst, 043200; 180550, comp lk scr 3. 5hex 4. 75x15 st, 426330; 180551, comp lk scr 3. 5hex 4. 75x20 st, 220010; 180552, comp lk scr 3. 5hex 4. 75x25 st, 603170; 406669, stn pn thd tip. 125x2. 5in 2pk, 222510; 106021, ringloc+ replacement ring sz21, 684250. Event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[123748299]
It was reported that during a primary comprehensive reverse shoulder procedure, the poly liner failed to seat into the humeral tray. Final seating did not result in the ring-lock mechanism correctly locking. The procedure was completed with a new liner. Resultant construct was tighter than ideal, and extra bone removal was required to prevent impingement. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-09288 |
| MDR Report Key | 7966785 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-10-15 |
| Date of Report | 2019-02-05 |
| Date of Event | 2018-09-18 |
| Date Mfgr Received | 2019-02-05 |
| Device Manufacturer Date | 2018-04-02 |
| Date Added to Maude | 2018-10-15 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E1 44-36 STD HMRL BRNG |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | PAO |
| Date Received | 2018-10-15 |
| Returned To Mfg | 2018-10-31 |
| Model Number | N/A |
| Catalog Number | EP-115393 |
| Lot Number | 536010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-10-15 |