MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-08-28 for SUBCHONDROPLASTY N/A UNKNOWN manufactured by Zimmer Knee Creations, Inc..
[155952995]
On 29 july 2019, zimmerbiomet was notified by the fda of an event via medwatch number mw5088155. A patient had reported that after the initial subchondroplasty procedure on (b)(6) 2015, they experienced increased pain, and at follow-up appointments, received steroid injections, physical therapy, and four additional procedures, including a total knee replacement in 2016 and a tka revision in 2017. The patient had two mri images taken in 2015, and a ct in 2016. Additionally, the patient underwent a spinal fusion in 2009. Once additional information becomes available about the event, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[155952996]
Patient suffering pain and disability after scp and tka.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2019-00042 |
| MDR Report Key | 8940153 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2019-08-28 |
| Date of Report | 2019-08-28 |
| Date of Event | 2015-03-17 |
| Date Facility Aware | 2019-07-31 |
| Report Date | 2019-07-12 |
| Date Reported to FDA | 2019-07-12 |
| Date Reported to Mfgr | 2019-07-29 |
| Date Mfgr Received | 2019-07-29 |
| Date Added to Maude | 2019-08-28 |
| 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 | MR. LEO MUNAR |
| Manufacturer Street | 841 SPRINGDALE DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal | 19341 |
| Manufacturer Phone | 4848794553 |
| Manufacturer G1 | ZIMMER KNEE CREATIONS, INC. |
| Manufacturer Street | 841 SPRINGDALE DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUBCHONDROPLASTY |
| Generic Name | SCP KIT |
| Product Code | OJH |
| Date Received | 2019-08-28 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER KNEE CREATIONS, INC. |
| Manufacturer Address | 841 SPRINGDALE DRIVE EXTON PA 19341 US 19341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-28 |