MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-06-11 for MENAFLEX IMPLANT (MEDIAL) 9.0 MM MEDIAL P/N 4601 manufactured by Regen Biologics, Inc..
[1620703]
The reporting surgeon (b) (6) implanted a 9. 0mm medial menaflex device on (b) (6) 2009, in the right knee of a female, pt. The pt had 2 prior partial meniscectomies. At the time of menaflex surgery, the pt had minimal remnants of the medial meniscus with horizontal clefts and an area of 0. 5 x 1. 0cm grade iv articular cartilage damage on the medial tibial plateau. The surgeon implanted a medial 9. 0mm menaflex device cut to 5cm in length. The device was implanted using one fast-fix device posterior , 3 fast-fix along the vertical rim and one inside-out suture in the anterior horn. The grade iv damage was treated by microfracture. Post-operative course was normal through discharge. The surgeon reported to regen that approx 3 months post-operatively, the pt started to have recurrent effusions. The surgeon performed and arthroscopic examination of the knee joint on (b) (6) 2009. The surgery revealed; effusion, several white pieces of tissue, possibly remnants of the menaflex device and synovitis. The joint was flushed and it was noted that the menaflex device was frayed in the posterior horn, but well integrated anteriorly with some local defects. Any loose menaflex fragments were debrided to an stable rim, leaving the well integrated portions of the implant and tissue complex within the joint. Some removed remanants of the device were submitted for pathology. A synovectomy was performed along with a debridement of the retropatella surface. Following extensive lavage, the pt was continued on antibiotic treatment.
Patient Sequence No: 1, Text Type: D, B5
[8600570]
The menaflex device used is a 9. 0mm medial menaflex implant pn4601 from lot # 07h273. This was from a manufactured lot size of 24 devices. Of the 24 devices, 7 were taken as qa retains and 17 were labeled and released for export commercial distribution. Since all records indicate that the product meets all established specs and no product was returned for examination, the cause of this incident cannot be reasonably identified. Post-operative synovitis, effusions, reaction to the implant material, and failure of the device to fully incorporate into the host meniscus are all risks that have been identified in the labeling of the product and as such do not constitute unanticipated adverse events. In addition, the grade iv articular damage in the medial compartment of the knee, that was noted at the time of menaflex implantation, could potentially cause damage to the implant resulting in fragmentation of the device and is a contraindication in the labeling of the device. Regen will monitor any future such response to the device; however, based on the current investigation, no need for corrective action is warranted. Should additional substantive info be received, this complaint will be reopened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2956141-2010-00002 |
| MDR Report Key | 1725348 |
| Report Source | 05 |
| Date Received | 2010-06-11 |
| Date of Report | 2009-06-11 |
| Date of Event | 2009-10-28 |
| Date Mfgr Received | 2010-03-18 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2010-06-18 |
| 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 | JOHN DICHIARA |
| Manufacturer Street | 545 PENOBSCOT DR. |
| Manufacturer City | REDWOOD CITY CA 94063 |
| Manufacturer Country | US |
| Manufacturer Postal | 94063 |
| Manufacturer Phone | 6503068294 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MENAFLEX IMPLANT (MEDIAL) |
| Generic Name | OLC - SURGICAL MESH |
| Product Code | OLC |
| Date Received | 2010-06-11 |
| Model Number | 9.0 MM MEDIAL |
| Catalog Number | P/N 4601 |
| Lot Number | 07H273 |
| Device Expiration Date | 2009-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REGEN BIOLOGICS, INC. |
| Manufacturer Address | REDWOOD CITY CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-06-11 |