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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Granuloma (1876); Pain (1994); Swelling (2091); Palpitations (2467)

Event Type  Injury  

Event Description

J foot ankle surg.2005 may - jun; 44(3): 203-10 caminear, d.S., et al information was received based on review of a journal article titled, "fixation of the chevron osteotomy with an absorbable copolymer pin for treatment of hallux valgus deformity¿ which investigated the use of a bioabsorbable pin made of an oriented poly-l-lactic acid/polyglycolic acid (82:18 ratio) copolymer to fix distal chevron osteotomies.The study was conducted over a period of one (1) year (january 17, 2000, and september 7, 2001) and involved fifteen (15) patients (eighteen (18) feet).The journal article reports the following manipulation: cyst debridement and giant cell granuloma discovery due to tenderness to palpation and mild swelling the authors of the study conclude that 1) a 2 mm diameter oriented 82:18 plla/pga copolymer pin, applied to fixate a distal chevron first metatarsal osteotomy, provided clinically relevant hallux valgus correction that was comparable to that provided by other forms of fixation, both metallic and bioabsorbable, and 2) complications following use of this implant were infrequent, and limited to a single case of a painful granuloma that was somewhat responsive to treatment.

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 patients mentioned in the journal article.The article was written by caminear ds et al.In j foot ankle surg.2005 may-jun;44(3):203-10.It is likely that these complications and revisions have already been reported; however, it cannot be determined based on the limited information made available in the article.Should additional information relating to the events be received, the updated information will be forwarded to the fda.

Manufacturer Narrative

The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.

Event Description

Information was received based on review of a journal article titled, "fixation of the chevron osteotomy with an absorbable copolymer pin for treatment of hallux valgus deformity which investigated the use of a bioabsorbable pin made of an oriented poly-l-lactic acid/polyglycolic acid (82:18 ratio) copolymer to fix distal chevron osteotomies.The study was conducted over a period of one (1) year (january 17, 2000, and september 7, 2001) and involved fifteen (15) patients (eighteen (18) feet).The journal article reports the following manipulation: cyst debridement and giant cell granuloma discovery due to tenderness to palpation and mild swelling.Additionally, two (2) patients complained of moderate pain post-op.The authors of the study conclude that 1) a 2 mm diameter oriented 82:18 plla/pga copolymer pin, applied to fixate a distal chevron first metatarsal osteotomy, provided clinically relevant hallux valgus correction that was comparable to that provided by other forms of fixation, both metallic and bioabsorbable, and 2) complications following use of this implant were infrequent, and limited to a single case of a painful granuloma that was somewhat responsive to treatment.

• Brand Name: UNKNOWN TRAUMA
• Type of Device: PIN, FIXATION
• 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: 4936618
• MDR Text Key: 6016395
• Report Number: 0001825034-2015-03244
• Device Sequence Number: 1
• Product Code: HTY
• 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,Followup
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2015
• Initial Date FDA Received: 07/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/04/2015
• 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): Hospitalization; Required Intervention