MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-10 for ATTUNE CONV FB PS TB TRL SZ7 254500977 manufactured by Depuy Ireland 9616671.
[132807306]
(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
[132807307]
It was reported that the sz 7 fb artic surf was broke. All pieces were retrieved. No surgical delay.
Patient Sequence No: 1, Text Type: D, B5
[133086437]
Product complaint # : (b)(4). The device associated with this report was not returned for evaluation. The investigation could not draw any conclusions about the reported event without the device to examine. 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, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2019-80445 |
| MDR Report Key | 8235489 |
| Date Received | 2019-01-10 |
| Date of Report | 2018-12-12 |
| Date of Event | 2018-12-12 |
| Date Mfgr Received | 2019-02-15 |
| Device Manufacturer Date | 2013-11-04 |
| Date Added to Maude | 2019-01-10 |
| 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 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| 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 | 0 |
| Brand Name | ATTUNE CONV FB PS TB TRL SZ7 |
| Generic Name | ATTUNE INSTRUMENTS : TIBIAL TRIALS |
| Product Code | KWH |
| Date Received | 2019-01-10 |
| Returned To Mfg | 2019-02-11 |
| Catalog Number | 254500977 |
| Lot Number | BFA0P7W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY IRELAND 9616671 |
| Manufacturer Address | LOUGHBEG, RINGASKIDDY CO. CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-10 |