MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-08 for UNKNOWN EXTREMITY N/A manufactured by Biomet Orthopedics.
[42316116]
Current information is insufficient to permit conclusions as to the cause of the events. The following sections could not be completed with the limited information provided. Date of event - unknown. Device code - unknown. Expiration date - unknown. Date implanted - unknown. Date explanted - unknown. Initial reporter - the article was written by khoury et al in the journal of foot & ankle surgery (2012) 10. 1053/j. Jfas. 2012. 04. 014. Pma/510(k) number. Manufacture date? Unknown. (b)(4). Product location unknown.
Patient Sequence No: 1, Text Type: N, H10
[42316117]
Information was received based on review of a journal article titled, "management of failed and infected first metatarsophalangeal joint implant arthroplasty by reconstruction with an acellular dermal matrix: a case report" which explored a new option of reconstructing the joint with an acellular dermal matrix substance in a single case study during a 12-month follow-up period. This study consisted of a (b)(6) year old female with a chief complaint of pain in the right first mtp joint with an onset of approximately 2 months previous to her presentation with no trauma to the area. The patient noted that her great toe had started to shorten and deform during that period. Ambulation seemed to make her pain and deformity worse. The patient experienced significant erythema and edema with what appeared to be an ulceration to the dorso-medial aspect of the joint. The initial radiographic examination revealed a koenig-type total joint, manufactured at biomet. Both phalangeal and metatarsal components were severely displaced with significant amounts of lucency noted at the stems of the implants. Complete dissolution of the proximal phalanx was noted, and the phalangeal stem was resting on top of the distal phalanx. Diagnosis was a failed total joint with concurrent ulceration and infection. Patient underwent debridement and removal of the total joint implant. In this case, the surgeon successfully incorporated the acellular dermal matrix into the first mtp joint after removal of the failed 2-component implant and resection of the necrotic proximal phalanx and distal first metatarsal bones. In conclusion, although current data are lacking on this approach, the results of this case have shown that adequate function, pain relief, and early weight-bearing can certainly be achieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2016-01198 |
| MDR Report Key | 5562851 |
| Date Received | 2016-04-08 |
| Date of Report | 2016-03-10 |
| Date Mfgr Received | 2016-03-10 |
| Date Added to Maude | 2016-04-08 |
| 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 | MS. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN EXTREMITY |
| Generic Name | PROSTHESIS, TOE |
| Product Code | KWH |
| Date Received | 2016-04-08 |
| Model Number | N/A |
| Catalog Number | UNKNOWN EXTREMITY |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-04-08 |