MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-07-24 for DELTA 76539166 manufactured by Smith&nephew ? Germany.
[10029077]
The site registration code should be (b)(4), not (b)(4). The incorrect code was inadvertently submitted. We apologize for any inconvenience.
Patient Sequence No: 1, Text Type: N, H10
[20089870]
It was reported that a revision surgery was performed due to dislocations. Also, it was reported the surgeon declared the stem was well integrated and the damage didn't warrant the removal of the stem. In addition, it was noted that the liner was correctly seated from time of primary surgery.
Patient Sequence No: 1, Text Type: D, B5
[20209039]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2012-00400 |
| MDR Report Key | 2667464 |
| Report Source | 05,07 |
| Date Received | 2012-07-24 |
| Date of Report | 2012-07-05 |
| Date of Event | 2012-06-29 |
| Date Mfgr Received | 2012-07-05 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2012-07-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR PHILLIP EMMERT |
| Manufacturer Street | 1450 E. BROOKS RD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995296 |
| Manufacturer G1 | SMITH&NEPHEW |
| Manufacturer Street | ALEMANNENSTRASSE 14 |
| Manufacturer City | TUTTLINGEN TN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DELTA |
| Generic Name | ACETABULAR HEAD COMPONENT |
| Product Code | LPF |
| Date Received | 2012-07-24 |
| Catalog Number | 76539166 |
| Lot Number | 09JT35810 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH&NEPHEW ? GERMANY |
| Manufacturer Address | ALEMANNENSTRASSE 14 TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-07-24 |