MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-08-18 for CAS PSI KNEE SYSTEM N/A 20-8070-002-01 manufactured by Zimmer Cas.
[52398537]
Product code oog. It was reported by the sales rep that on the six month post-op follow up, the patient had a hka of 12 degrees valgus. Multiple attempts to obtain a standing long leg x-ray from the surgeon for evaluation were unsuccessful. No additional information is available for further investigation of this event. Not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[52398538]
It was reported by the sales rep the surgeon stated that on the six month post-op follow up, the patient had a hip-knee-ankle (hka) alignment of 12 deg valgus. Multiple attempts were made to confirm the outcome, but, without success. It is not known if any additional medical intervention was undertaken to correct the patient's post-op condition, and no additional information is available for further investigation of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009617840-2016-00024 |
| MDR Report Key | 5885392 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-08-18 |
| Date of Report | 2015-05-19 |
| Date of Event | 2014-09-11 |
| Date Mfgr Received | 2015-05-19 |
| Device Manufacturer Date | 2014-08-15 |
| Date Added to Maude | 2016-08-18 |
| 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. ISABELLE LAFRAMBOISE |
| Manufacturer Street | 75 QUEEN STREET SUITE 3300 |
| Manufacturer City | MONTREAL, QUEBEC H3C 2N6 |
| Manufacturer Country | CA |
| Manufacturer Postal | H3C 2N6 |
| Manufacturer Phone | 51486 |
| Manufacturer G1 | ZIMMER CAS |
| Manufacturer Street | 75 QUEEN STR. SUITE 3300 |
| Manufacturer City | MONTREAL, QUEBEC H3C 2N6 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | H3C 2N6 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAS PSI KNEE SYSTEM |
| Generic Name | KNEE ARTHROPLASTY IMPLANTATION SYSTEM |
| Product Code | OOG |
| Date Received | 2016-08-18 |
| Model Number | N/A |
| Catalog Number | 20-8070-002-01 |
| Lot Number | TRA1B7L46MM14US |
| ID Number | N/A |
| Device Expiration Date | 2015-02-28 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER CAS |
| Manufacturer Address | 75 QUEEN STR. SUITE 3300 MONTREAL, QUEBEC H3C 2N6 CA H3C 2N6 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-18 |