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 2019-05-01 for COMP PRIMARY STEM 13MM MINI N/A 113633 manufactured by Zimmer Biomet, Inc..
[143673996]
(b)(4). Concomitant medical products: item 115330, lot 256930, comp rvrs shdr glen bsplt +ha. Item 115320, lot 742540, comp rvrs shldr glnsp std 41mm. Item 115383, lot 468490, comp rvs cntrl scr 6. 5x35mm st. Item 118001, lot 414650, versa-dial/comp ti std taper. Item 180500, lot 029310, comp locking screw 4. 75x15mm. Item 180501, lot 851420, comp locking screw 4. 75x20mm. Item 180504, lot 851970, comp locking screw 4. 75x35mm. Item 180503, lot 257240, comp locking screw 4. 75x30mm. Item xl-115366, lot 469720, acrom xl 44-41 std hmrl brng. Item 115340, lot 659970, comp rvs hmrl ti tray 44mm. Multiple mdr reports were filed for this event. 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 not returned.
Patient Sequence No: 1, Text Type: N, H10
[143673997]
It was reported that patient underwent right reverse total shoulder arthroplasty. Subsequently, the patient developed progressive numbness in the right hand requiring an ulnar nerve transposition, approximately 4 months post surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-01846 |
| MDR Report Key | 8568566 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-01 |
| Date of Report | 2019-09-10 |
| Date of Event | 2010-03-30 |
| Date Mfgr Received | 2019-08-16 |
| Device Manufacturer Date | 2009-08-01 |
| Date Added to Maude | 2019-05-01 |
| 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 13MM MINI |
| Generic Name | EXTREMITIES, IMPLANT |
| Product Code | MBF |
| Date Received | 2019-05-01 |
| Model Number | N/A |
| Catalog Number | 113633 |
| Lot Number | 748600 |
| Device Expiration Date | 2019-08-31 |
| 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. Other | 2019-05-01 |