MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-21 for VANGUARD SSK 360 FEMUR L 62.5 N/A 185283 manufactured by Zimmer Biomet, Inc..
[112189594]
(b)(4). (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-04115 and 0001825034-2018-04116. Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. 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.
Patient Sequence No: 1, Text Type: N, H10
[112189595]
It was reported that during stock investigation the sterile packaging was found to be cracked and deformed. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-04116 |
| MDR Report Key | 7626238 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-21 |
| Date of Report | 2019-01-31 |
| Date Mfgr Received | 2019-01-25 |
| Device Manufacturer Date | 2015-02-11 |
| Date Added to Maude | 2018-06-21 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | VANGUARD SSK 360 FEMUR L 62.5 |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2018-06-21 |
| Returned To Mfg | 2018-11-12 |
| Model Number | N/A |
| Catalog Number | 185283 |
| Lot Number | 3515129 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-06-21 |