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 2018-10-09 for COMPREHENSIVE REVERSE HUMERAL BEARING N/A XL-115363 manufactured by Zimmer Biomet, Inc..
[123116472]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device product code-phx. Unique identifier (udi) #: (b)(4). Concomitant medical products: item # 115370, comp rvs tray co 44mm, lot #163650; item # 115310, comp rvrs shldr glnsp std 36mm, lot # 961680; item # 180550, comp lk scr 3. 5hex 4. 75x15 st, lot # 331030; item # 180554, comp lk scr 3. 5hex 4. 75x35 st, lot # 028240; item # 010000589, comp rvrs 25mm bsplt ha+adptr, lot # 017540; item # 180550, comp lk scr 3. 5hex 4. 75x15 st, lot # 135680; item # 115396, comp rvs cntrl 6. 5x30mm st/rst, lot # 391730; item # 406669, stn pn thd tip. 125x2. 5in 2pk, lot # 354400; item # 113635, comp primary stem 15mm mini, lot # 231180. Report source: legal notification. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 09190.
Patient Sequence No: 1, Text Type: N, H10
[123116473]
It was reported that approximately two (2) weeks post implantation, the patient had presented to the clinic with a right prosthetic shoulder dislocation without any traumatic event, and underwent a revision surgery. During the revision, the humeral tray and bearing were revised. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-09191 |
| MDR Report Key | 7947953 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-10-09 |
| Date of Report | 2018-09-26 |
| Date of Event | 2016-12-20 |
| Date Mfgr Received | 2018-09-11 |
| Device Manufacturer Date | 2016-11-18 |
| Date Added to Maude | 2018-10-09 |
| 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 | COMPREHENSIVE REVERSE HUMERAL BEARING |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | MJT |
| Date Received | 2018-10-09 |
| Model Number | N/A |
| Catalog Number | XL-115363 |
| Lot Number | 884300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-10-09 |