MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2015-08-24 for UNKNOWN TRAUMA N/A manufactured by Biomet Orthopedics.
[23825655]
Current information is insufficient to permit conclusions as to the cause of the events. Event details and product identification was not provided for the patient mentioned in the journal article. The following sections could not be completed with the limited information provided. Date of event - unknown. Expiration date - unknown. Date implanted - unknown. Date explanted - unknown. Initial reporter - the article was written by pavlovich, r. Et al in the journal of foot & ankle surgery 42(4):226-229, 2003. Manufacture date? Unknown.
Patient Sequence No: 1, Text Type: N, H10
[23825656]
Information was received based on review of a journal article titled, "granuloma formation after chevron osteotomy fixation with absorbable copolymer pin: a case report" which reports the occurrence of granuloma formation after a chevron osteotomy after using a lactosorb copolymer pin, manufactured at biomet. A (b)(6) woman presented 5 months after a bunionectomy and complained of pain with activity and constriction with conventional shoe gear. At 3 months after surgery, her postoperative course had been unremarkable, with gradual abatement of her preoperative pain, restoration of preoperative range of motion, and an uneventful transition to conventional shoe gear. The bunionectomy consisted of a chevron osteotomy fixated with a plla/pga copolymer pin. Physical examination showed a full range of motion with tenderness to palpation and mild swelling without erythema or fluctuance. Plain radiographs showed a well-aligned, consolidated osteotomy with mild cystic changes of the first metatarsal head. Approximately 11 months after her initial surgery, persistent pain and swelling prompted an exploration and biopsy of the cystic area of the left first metatarsal head. Permanent section analysis was interpreted as giant-cell granuloma formation. Results of a tissue culture and staining failed to show the presence of microorganisms. In an effort to decrease the incidence of foreign-body reactions, researchers have attempted to achieve a balance between degradation times and implant strength. The advent of copolymer fixation devices was a result of these efforts. However, with current implant composition, foreign-body reaction can still occur, which may compromise outcomes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2015-03703 |
| MDR Report Key | 5024678 |
| Report Source | LITERATURE |
| Date Received | 2015-08-24 |
| Date of Report | 2015-07-31 |
| Date Mfgr Received | 2015-07-31 |
| Date Added to Maude | 2015-08-24 |
| 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 | 3 |
| Brand Name | UNKNOWN TRAUMA |
| Generic Name | FIXATION, PIN |
| Product Code | OVZ |
| Date Received | 2015-08-24 |
| Model Number | N/A |
| Catalog Number | UNKNOWN TRAUMA |
| Lot Number | UNKNOWN LOT |
| 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. Required No Informationntervention | 2015-08-24 |