MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-08 for N/A 307.032 manufactured by Zimmer Knee Creations, Inc..
[77002106]
The investigation is still in-process as well as the evaluation of the returned device section. When the investigation is complete a supplemental medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[77002107]
Accuport broke inside patient was explanted (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2017-00016 |
| MDR Report Key | 6622498 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-08 |
| Date of Report | 2017-10-09 |
| Date of Event | 2017-05-11 |
| Date Mfgr Received | 2017-05-11 |
| Date Added to Maude | 2017-06-08 |
| 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. SHARI BAILEY |
| Manufacturer Street | 841 SPRINGDALE DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal | 19341 |
| Manufacturer Phone | 4848794543 |
| 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 |
| Product Code | FGY |
| Date Received | 2017-06-08 |
| Model Number | N/A |
| Catalog Number | 307.032 |
| Lot Number | UNK |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-06-08 |