MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2013-09-24 for PLUS 75004174 manufactured by Smith&nephew.
[3718373]
It was reported that a revision surgery was performed due to implant breakage after the patient fell from a ladder.
Patient Sequence No: 1, Text Type: D, B5
[11084839]
.
Patient Sequence No: 1, Text Type: N, H10
[11708997]
Conclusion: based on the received information it is reasonable to conclude that the root cause of the reported ceramic ball head was a traumatic event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613369-2013-00079 |
| MDR Report Key | 3365021 |
| Report Source | * |
| Date Received | 2013-09-24 |
| Date of Report | 2013-09-18 |
| Date of Event | 2013-09-18 |
| Date Mfgr Received | 2013-09-18 |
| Device Manufacturer Date | 2010-10-14 |
| Date Added to Maude | 2013-09-24 |
| 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 | SCHACHENALLEE 29 |
| Manufacturer City | AARAU CH5000 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH5000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLUS |
| Generic Name | CERAMIC CERAMIC BALL HEAD 32L |
| Product Code | LPF |
| Date Received | 2013-09-24 |
| Returned To Mfg | 2013-09-23 |
| Catalog Number | 75004174 |
| Lot Number | C1022792 |
| Device Expiration Date | 2017-10-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH&NEPHEW |
| Manufacturer Address | SCHACHENALLEE 29 AARAU CH5000 SZ CH5000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-09-24 |