MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-09-17 for HI LNR BIOLOX FORTE 0030933 75001073 manufactured by Smith & Nephew Orthopaedics Ag.
[4837144]
Revision surgery was reported due to pain. At revision surgery pronounced arthrofibrosis was detected.
Patient Sequence No: 1, Text Type: D, B5
[18130319]
For investigation a hi-lubricer ceramic insert and a ceramic ball head from a third-party manufacturer were received. The damage of the face of the insert and the metal transfer markings visible on the articular surfaces were likely caused during revision. On the insert as well as on the ball head are matt areas visible which suggest repeated micro separation and edge loading of the insert. The metal transfer markings visible on the cone of the insert suggest an adequate connection between insert and acetabular shell. The received pre revision radiograph shows a limb length difference with a decrease in length of the operated side. During primary intervention implants? Components from different manufacturers have been utilized. The combination of products supplied by the smith & nephew orthopaedics ag with products from third-party manufacturers is not allowed except with explicit direction from the product information, the surgical technique or the package insert stating that the combination of the implant systems is allowed. The information contained in the received surgical report of revision suggests that the pain experienced from the patient was likely due to psoas tendon impingement with the prosthetic components.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613369-2014-00088 |
| MDR Report Key | 4094755 |
| Report Source | 01,07 |
| Date Received | 2014-09-17 |
| Date of Report | 2014-09-05 |
| Date of Event | 2014-09-01 |
| Date Mfgr Received | 2014-09-05 |
| Device Manufacturer Date | 2007-02-15 |
| Date Added to Maude | 2014-09-17 |
| 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 | MRS TINA MUELLER |
| Manufacturer Street | OBERNEUHOFSTRASSE 10D |
| Manufacturer City | 6340 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 6340 |
| Manufacturer Phone | 0628320660 |
| Manufacturer G1 | SMITH & NEPHEW ORTHOPAEDICS AG |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5000 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 5000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HI LNR BIOLOX FORTE |
| Generic Name | HI-LUBRICER CERAMIC INSERT STD. 3-5/28 |
| Product Code | LPF |
| Date Received | 2014-09-17 |
| Returned To Mfg | 2014-09-25 |
| Model Number | 0030933 |
| Catalog Number | 75001073 |
| 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 ORTHOPAEDICS AG |
| Manufacturer Address | SCHACHENALLEE 29 AARAU CH5000 SZ CH5000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2014-09-17 |