MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-12-12 for RENOVIS A400 1401-322-135 manufactured by Renovis Surgical Technologies.
[130161159]
The following renovis implants were utilized in this surgery:? 6. 5mm x 30mm, cancellous bone screw, p/n 1501-865-030, lot # 10914-1;? 56mm t3 shell, cluster hole,3/8 dome hole plug, p/n 1501-161-056, lot # 10985-4;? 36mm x 56/58mm universal liner, hooded, emax, p/n 1527-365-658, lot # 2178-6;? 36mm, -4mm ceramic femoral head, p/n 1451-036-004, lot # 11233-1;? 13. 5mm tapered standard offset, p/n 1401-322-135, lot # 2503-1. Renovis ifu 4401-001 lists possible adverse effects associated with total hip arthroplasty, including "early or late postoperative infection. " an internal review of related device history records revealed all devices met product specifications, including material specifications and sterilization requirements. The investigation could not verify or identify any evidence of product contribution to the reported problem. Surgical notes were not provided. X-rays were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. Patient factors that may affect the performance of the components such as bone quality, height/weight, activity level, type of activity (low impact vs. High impact), etc. , are unknown. A definitive root cause cannot be determined with the information provided.
Patient Sequence No: 1, Text Type: N, H10
[130161160]
A representative contacted customer service regarding an instrument which had broken during a hip implant revision surgery. Upon further questioning, the representative stated that the implant was extracted due to patient infection which was not responding to non-surgical treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007932279-2018-00002 |
| MDR Report Key | 8156224 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-12-12 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-11-02 |
| Date Mfgr Received | 2018-11-02 |
| Device Manufacturer Date | 2015-10-05 |
| Date Added to Maude | 2018-12-12 |
| 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 | MRS. RACHELLE HEMINGER |
| Manufacturer Street | 1901 W. LUGONIA AVE SUITE 340 |
| Manufacturer City | REDLANDS CA 92374 |
| Manufacturer Country | US |
| Manufacturer Postal | 92374 |
| Manufacturer Phone | 9095572360 |
| Manufacturer G1 | RENOVIS SURGICAL TECHNOLOGIES |
| Manufacturer Street | 1901 W. LUGONIA AVE. SUITE 340 |
| Manufacturer City | REDLANDS CA 92374 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92374 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENOVIS |
| Generic Name | TAPERED FEMORAL STEM, STD OFFSET, 13.5MM |
| Product Code | OQI |
| Date Received | 2018-12-12 |
| Model Number | A400 |
| Catalog Number | 1401-322-135 |
| Lot Number | 2503-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RENOVIS SURGICAL TECHNOLOGIES |
| Manufacturer Address | 1901 W. LUGONIA AVE. SUITE 340 REDLANDS CA 92374 US 92374 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-12 |