MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-21 for 9.0MM CMI - MEDIAL (INTERNATIONAL) 4601 manufactured by Stryker Endoscopy-san Jose.
[103135214]
The product was not returned for investigation therefore the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence. Alleged failure: patient got pain since implantation and patella bruise probable root cause: infection associated with any arthroscopic procedure. The device manufacturer date is not known. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103135215]
It was reported that revision surgery is necessary due to patient pain..
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002956141-2018-00001 |
| MDR Report Key | 7360191 |
| Date Received | 2018-03-21 |
| Date of Report | 2018-03-21 |
| Date of Event | 2018-01-05 |
| Date Mfgr Received | 2018-02-22 |
| Date Added to Maude | 2018-03-21 |
| 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 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. VALERIE ESTRADA |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 9.0MM CMI - MEDIAL (INTERNATIONAL) |
| Generic Name | SCAFFOLD, PARTIAL MEDIAL MENISCAL DEFECTS EXTENDING INTO THE RED/WHITE ZONE, RES |
| Product Code | OLC |
| Date Received | 2018-03-21 |
| Catalog Number | 4601 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-21 |