MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN EXTREMITY; PROSTHESIS, TOE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Unspecified Infection (1930); Pain (1994); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: UNKNOWN EXTREMITY
• Type of Device: PROSTHESIS, TOE
• 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: 5562851
• MDR Text Key: 42316116
• Report Number: 0001825034-2016-01198
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• 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 EXTREMITY
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 71 YR