MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-03-13 for COMP PRIMARY STEM N/A 113646 manufactured by Zimmer Biomet, Inc..
[138719682]
(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[138719683]
It was reported by the distributor the product arrived damaged with sterility barrier potentially compromised. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-01208 |
| MDR Report Key | 8417796 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-03-13 |
| Date of Report | 2019-03-13 |
| Date Mfgr Received | 2019-02-18 |
| Device Manufacturer Date | 2018-08-29 |
| Date Added to Maude | 2019-03-13 |
| 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 |
| Generic Name | PROSTHESIS, HIP |
| Product Code | MBF |
| Date Received | 2019-03-13 |
| Returned To Mfg | 2019-02-18 |
| Model Number | N/A |
| Catalog Number | 113646 |
| Lot Number | 306110 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-03-13 |