MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,health p report with the FDA on 2019-01-07 for COMP PRIMARY STEM 14MM MINI N/A 113634 manufactured by Zimmer Biomet, Inc..
[132230705]
(b)(4). Multiple mdr's were filed for this event. Please see associated report(s): 0001825034 - 2018 - 11335, 0001825034 - 2018 - 11338, 0001825034 - 2018 - 11351, 0001825034 - 2018 - 11352, 0001825034 - 2018 - 11353, 0001825034 - 2018 - 11354, 0001825034 - 2018 - 11355, 0001825034 - 2018 - 11356. (b)(4). Concomitant medical products: item # 115397 comp rvs cntrl 6. 5x35mm st/rst lot 351970, 180550 comp lk scr 3. 5hex 4. 75x15 st lot 115560, 010000589 comp rvrs 25mm bsplt ha+adptr lot 180780, 180551 comp lk scr 3. 5hex 4. 75x20 st lot 238420, 180551 comp lk scr 3. 5hex 4. 75x20 st lot 238400, 115310 comp rvrs shldr glnsp std 36mm lot 128420, 113634 comp primary stem 14mm mini lot 213860, 115370 comp rvs tray co 44mm lot 752390. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[132230706]
It was reported the patient was revised to address pain with loss of range of motion and component loosening secondary to glenosphere disassociation in-vivo. No further information available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-11355 |
| MDR Report Key | 8222255 |
| Report Source | CONSUMER,DISTRIBUTOR,HEALTH P |
| Date Received | 2019-01-07 |
| Date of Report | 2019-04-22 |
| Date of Event | 2018-06-26 |
| Date Mfgr Received | 2019-04-18 |
| Device Manufacturer Date | 2017-04-13 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMP PRIMARY STEM 14MM MINI |
| Generic Name | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED |
| Product Code | MBF |
| Date Received | 2019-01-07 |
| Model Number | N/A |
| Catalog Number | 113634 |
| Lot Number | 213860 |
| 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 | 2019-01-07 |