MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN TRAUMA; FIXATION, PIN

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Foreign Body Reaction (1868); Granuloma (1876); Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: UNKNOWN TRAUMA
• Type of Device: FIXATION, PIN
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5024678
• MDR Text Key: 23825655
• Report Number: 0001825034-2015-03703
• Device Sequence Number: 1
• Product Code: OVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN TRAUMA
• Device Lot Number: UNKNOWN LOT
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR