MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-01-29 for BIOLOX 76539155 manufactured by Smith & Nephew, Inc..
[11750000]
The biolox forte ceramic liner fractured due to a brittle failure mechanism. The liner fractured in a mechanical overload scenario, which can occur if the forces applied to the device exceed the strength of the material. Metal transfer was found on the backside and on the articulating surface of the liner. Metal transfer was also found on the articulating surface of the femoral head. Deformation and scratches along the rim of the acetabular cup were also observed. It is unknown from the information provided if the observed metal transfer and deformation on these components were sustained during removal of the device or were due to impingement of the components in vivo. There was also metal transfer within the female taper region of the femoral head, which is likely where it came into contact with the stem.
Patient Sequence No: 1, Text Type: N, H10
[20636784]
It was reported that revision surgery was performed.
Patient Sequence No: 1, Text Type: D, B5
[21116314]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2014-00050 |
| MDR Report Key | 3597095 |
| Report Source | 07 |
| Date Received | 2014-01-29 |
| Date of Report | 2014-01-09 |
| Date of Event | 2014-01-09 |
| Date Mfgr Received | 2014-01-09 |
| Date Added to Maude | 2014-01-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. MELANIE TRAVIS |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013996233 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOLOX |
| Generic Name | FEMORAL COMPONENT |
| Product Code | LPF |
| Date Received | 2014-01-29 |
| Catalog Number | 76539155 |
| Lot Number | 12ET19165 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2014-01-29 |