MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-28 for BIOMET CC CRUCIATE TRAY 75MM N/A 141234 manufactured by Zimmer Biomet, Inc..
[146219035]
(b)(4). Concomitant medical products: intramedullary plug lge catalog 130613 lot 949880, vanguard cr ilok fem-rt 72. 5 catalog 183013 lot j6357372, series a pat thn 34 3 peg catalog 184786 lot 155370, e1 vngd as tib brg 16x75 catalog ep-189086 lot 537470. Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded by the user facility. 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
[146219036]
It was reported that during a follow up approximately three weeks post knee arthroplasty, the locking bar was noted to have backed out of the tibial tray. The patient then underwent a revision to replace the locking bar and tibial bearing. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-02323 |
| MDR Report Key | 8645517 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-28 |
| Date of Report | 2019-11-27 |
| Date of Event | 2019-04-25 |
| Date Mfgr Received | 2019-11-27 |
| Device Manufacturer Date | 2018-11-19 |
| Date Added to Maude | 2019-05-28 |
| 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 | BIOMET CC CRUCIATE TRAY 75MM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2019-05-28 |
| Model Number | N/A |
| Catalog Number | 141234 |
| Lot Number | J6432178 |
| 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 | 2019-05-28 |