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..
[123076592]
(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. Product code: phx. Unique identifier (udi) #: (b)(4). Concomitant medical products: item # 115378, comp rvs tray +10mm co 44mm, lot #905990. 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 # 115310, comp rvrs shldr glnsp std 36mm, lot # 961680. 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. Legal notification. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-09193, 0001825034-2018-09195, 0001825034-2018-09196, 0001825034-2018-09197, 0001825034-2018-09198, 0001825034-2018-09199, 0001825034-2018-09200, 0001825034-2018-09201, 0001825034-2018-09202.
Patient Sequence No: 1, Text Type: N, H10
[123076593]
It was reported that approximately three (3) months post implantation, the patient underwent a revision to have the shoulder prosthesis removed with irrigation and debridement and the placement of an antibiotic spacer. It is further alleged that the patient continued to have antibiotic treatment for infection from the 2nd revision, until present time. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-09194 |
| MDR Report Key | 7946927 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-10-09 |
| Date of Report | 2018-09-26 |
| Date of Event | 2017-03-05 |
| 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 | 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 | 2018-10-09 |