MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-08-31 for COMP RVSR SHLDR GLNSP +3 36MM N/A 115313 manufactured by Zimmer Biomet, Inc..
[118914041]
(b)(4). Concomitant medical products: xl-115363 arcom xl 44-36 std hmrl brng 285250; 115370 comp rvs tray co 44mm 652170; 115330 comp rvrs shdr glen bsplt +ha 786790; 118001 versa-dial/comp ti std taper 352400; 113636 comp primary stem 16mm mini 614090; 115396 comp rvs cntrl 6. 5x30mm st/rst 331330; 180554 comp lk scr 3. 5hex 4. 75x35 st 602980; 180550 comp lk scr 3. 5hex 4. 75x15 st 410190; 180550 comp lk scr 3. 5hex 4. 75x15 st 610760. The reported event can be confirmed based on the x-rays provided. X-ray review shows superior dislocation is confirmed. There is no fracture seen but the glenosphere appeared to be somewhat inferiorly positioned. Review of device history records found these units were released to distribution with no related deviations or anomalies. A definitive root cause cannot be determined based on the information provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2018 -08513.
Patient Sequence No: 1, Text Type: N, H10
[118914042]
It was reported that the patient underwent a revision due to dislocation of the right shoulder after one year post implantation. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-08636 |
| MDR Report Key | 7837487 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-08-31 |
| Date of Report | 2018-08-30 |
| Date of Event | 2018-07-31 |
| Date Mfgr Received | 2018-08-04 |
| Device Manufacturer Date | 2017-09-22 |
| Date Added to Maude | 2018-08-31 |
| 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 | COMP RVSR SHLDR GLNSP +3 36MM |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | PAO |
| Date Received | 2018-08-31 |
| Model Number | N/A |
| Catalog Number | 115313 |
| Lot Number | 142560 |
| 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 | 2018-08-31 |