MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-11-16 for MBT REVISION T-HANDLE 217863137 manufactured by Depuy Orthopaedics, Inc. 1818910.
[127459248]
Product complaint # (b)(4). 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
[127459249]
It was reported that both mbt reamer attachments stripped out while reaming hard bone.
Patient Sequence No: 1, Text Type: D, B5
[132840436]
Product complaint # (b)(4). Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may 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
| Report Number | 1818910-2018-75827 |
| MDR Report Key | 8080722 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-16 |
| Date of Report | 2018-10-30 |
| Date of Event | 2018-10-30 |
| Date Mfgr Received | 2018-12-02 |
| Device Manufacturer Date | 2015-03-24 |
| Date Added to Maude | 2018-11-16 |
| 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. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 19380XXXX |
| Manufacturer Country | US |
| Manufacturer Postal | 19380XXXX |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465820988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MBT REVISION T-HANDLE |
| Generic Name | KNEE INSTRUMENT : HANDLES |
| Product Code | LHX |
| Date Received | 2018-11-16 |
| Catalog Number | 217863137 |
| Lot Number | NB94106 |
| 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, INC. 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-16 |