MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-10-16 for BIOMET ILOK PRI TIB TRAY 91MM NI 141218 manufactured by Zimmer Biomet, Inc..
[89460154]
Concomitant medical products: item#183686; lot#710360 - vngd ps tib brg 16x87/91mm, item#183113; lot#094360 - van ps open intl fem-rt 72. 5. The product was not available for return. Without the opportunity to examine the complaint product, root cause cannot be determined. Review of device history records found these units were released to distribution with no deviations or anomalies. Review of the complaint history identified additional complaints that were investigated, and it was determined that no further action is required due to the time frame over which the products were manufactured. Review of sterilization certification confirms devices were sterilized in accordance with (b)(4). Requested contact to verbally relay results to the customer. Device not returned; fda 92 inconclusive-root cause cannot be determined; known inherent risk of procedure; condition is addressed in package insert. Completion of the investigation relayed to australia contact via email on (b)(6). 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. This report is being submitted late as it has been identified in remediation.
Patient Sequence No: 1, Text Type: N, H10
[89460155]
It was reported that patient underwent right total knee arthroplasty on (b)(6). Subsequently, the patient was revised on (b)(6) due to loosening and infection. All components were removed and replace with spacer molds.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-08701 |
| MDR Report Key | 6951984 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-10-16 |
| Date of Report | 2017-10-13 |
| Date of Event | 2016-01-22 |
| Date Mfgr Received | 2016-02-24 |
| Device Manufacturer Date | 2012-02-16 |
| Date Added to Maude | 2017-10-16 |
| 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 ILOK PRI TIB TRAY 91MM |
| Generic Name | PROSTHESIS - KNEE |
| Product Code | MBV |
| Date Received | 2017-10-16 |
| Model Number | NI |
| Catalog Number | 141218 |
| Lot Number | 006630 |
| ID Number | NI |
| Device Expiration Date | 2016-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Hospitalization; 2. Required No Informationntervention | 2017-10-16 |