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 2019-01-07 for COMP RVRS SHLDR GLNSP STD 36MM N/A 115310 manufactured by Zimmer Biomet, Inc..
[132207500]
(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. Product device code - phx. (b)(4). Concomitant medical products: cp560865, 3. 5x30mm bone screw, lot 699380; cp560869, 3. 5x50 mm bone screw, lot 699420; 103533, 6. 5x30 mm low profile screw, lot 348740; 113862, 5x30 mm low profile screw, lot 517310; cp560867, 3. 5x40 mm bone screw, lot 699400; cp560863, 3. 5x20 mm bone screw, lot 742010; cp560864, 3. 5x25 mm bone screw, lot 699370; cp560866, 3. 5x35 mm bone screw, lot 699390; cp560861, 3. 5x10 mm bone screw, lot 699340; xl-115363, arcom xl 44-36 std hmrl brng, lot 386490; 115370, comp rvs tray, lot 648710; 115310, comp rvrs shldr glnsp, lot 594180; 118001, taper, lot 388050; 180552, screw, lot 612100; 180552, screw, lot 938320; 180553, screw, lot 425770; 180551, screw, lot 748420; 115397, comp rvs ccntrl 6. 5x35mm st/rst, lot 193820; pm555334, lt pm rvs glen, lot 429540; 211219, compr srs prox bdy, lot 652520; 211218, comp srs prox bdy, lot 539740. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2016-01159.
Patient Sequence No: 1, Text Type: N, H10
[132207501]
It was reported that approximately 4 months post implantation, the patient underwent a revision due to dislocation and instability. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-11413 |
| MDR Report Key | 8221687 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-07 |
| Date of Report | 2019-04-11 |
| Date of Event | 2016-06-08 |
| Date Mfgr Received | 2019-04-09 |
| Device Manufacturer Date | 2016-01-09 |
| Date Added to Maude | 2019-01-07 |
| 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 | COMP RVRS SHLDR GLNSP STD 36MM |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | PAO |
| Date Received | 2019-01-07 |
| Model Number | N/A |
| Catalog Number | 115310 |
| Lot Number | 594180 |
| 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 | 2019-01-07 |