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 2020-01-22 for BIOMET CC CRUCIATE TRAY 75MM N/A 141234 manufactured by Zimmer Biomet, Inc..
[176101148]
(b)(4). Medical product: van ps open intl fem-lt 70 catalog # 183132 lot # 490110, vngd ps tib brg 14x71/75mm catalog # 183644 lot # 231070, series a pat std 31 3 peg catalog # 184764 lot # 380260, stblecut hyperblade ao/sd. 054 catalog # 907238 lot # 506104, cobalt g-hv bone cement 40g catalog # 402283 lot # 849960, cobalt g-hv bone cement 40g catalog # 402283 lot # 590590, optivac kit 80gram double mix catalog # 417200 lot # 1904362, 1/8 quick rel drl sterile 2pk catalog # 32-486265 lot # 368110. Customer has indicated that the product will not be returned because it remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filled for this event: 0001825034-2020-00334, 0001825034-2020-00335, 0001825034-2020-00337. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[176101149]
It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient will be considered for revision due to pain. No revision procedure has been reported to date. Attempt for further information has been made, but no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-00336 |
| MDR Report Key | 9617517 |
| Report Source | CONSUMER,DISTRIBUTOR,HEALTH P |
| Date Received | 2020-01-22 |
| Date of Report | 2020-02-12 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2010-09-01 |
| Date Added to Maude | 2020-01-22 |
| 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 | 2020-01-22 |
| Model Number | N/A |
| Catalog Number | 141234 |
| Lot Number | 267800 |
| 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 | 2020-01-22 |