MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2018-08-13 for MBT REV TIBIAL VIEW PLT SZ2.5 217865125 manufactured by Depuy Orthopaedics Inc Us.
[116917839]
(b)(4). Investigation summary: examination of the returned view plate confirmed the reported event. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[116917840]
View plate has snapped in half. "this case has been reported by the loan kit technician during loan kit inspection. It has been forwarded to depuy engineering for assessment. No further information can be obtained as the case was not reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2018-66465 |
| MDR Report Key | 7777406 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2018-08-13 |
| Date of Report | 2018-07-19 |
| Date of Event | 2018-07-11 |
| Date Mfgr Received | 2018-07-19 |
| Device Manufacturer Date | 2015-09-24 |
| Date Added to Maude | 2018-08-13 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 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 | MBT REV TIBIAL VIEW PLT SZ2.5 |
| Generic Name | KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS |
| Product Code | LHX |
| Date Received | 2018-08-13 |
| Returned To Mfg | 2018-08-06 |
| Catalog Number | 217865125 |
| Lot Number | SO2020497 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-13 |