MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-12-22 for UNKNOWN DEPUY COMPONENT UNK-KNEE manufactured by Depuy Orthopaedics 1818910.
[63091172]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: unavailable.. Follow-up with the complainant has been conducted for the catalog number and lot number and this information is unavailable. This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10
[63091173]
Patient was revised to address loosening. Loosening occurred at an unknown interface. Cement manufacturer is unknown.
Patient Sequence No: 1, Text Type: D, B5
[66696593]
No device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Corrective action was not indicated. Depuy considers the investigation closed at this time. Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2016-33863 |
| MDR Report Key | 6198418 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-19 |
| Date of Event | 2016-12-19 |
| Date Mfgr Received | 2017-01-19 |
| Date Added to Maude | 2016-12-22 |
| 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 | CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN DEPUY COMPONENT |
| Generic Name | KNEE OTHER IMPLANT |
| Product Code | KRP |
| Date Received | 2016-12-22 |
| Catalog Number | UNK-KNEE |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-22 |