MAUDE Adverse Event Report: BIOMIMETIC THERAPEUTICS LLC, SUBSIDIARY OF WRIGHT AUGMENT BONE GRAFT; RH-PDGF AND BETA-TCP-BB COMBINATION DRUG DEVICE PRODUCT

Model Number N/A

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

Patient Problem Local Reaction (2035)

Event Date 12/04/2015

Event Type  Injury  

Manufacturer Narrative

Consumed/implanted during surgery.

Event Description

On (b)(6) 2015, a wright medical sales rep (for biomimetic therapeutics, a wholly owned subsidiary of wright medical group) was contacted by a surgeon named dr.(b)(6) regarding any previous reports of swelling and drainage around the incision site on a patient who underwent an ankle fusion, using augment bone graft.Three attempts were made to reach the surgeon to gain additional information relative to the patient outcome, leaving messages with the surgeon's medical assistant requesting a call back.The surgeon's medical assistant called a wright complaint coordinator on (b)(6) 2016, and reported the following: the involved patient is a (b)(6) female, (b)(6), who underwent fusion surgery on (b)(6) 2015 - specific surgical site not reported.The patient was seen in the in the surgeon's office on (b)(6) 2015, and the surgeon performed an incision and drainage of the swollen area.The medical assistant noted during the call on (b)(6)2015 that treatment was ongoing for the patient, and the surgical site was not yet healed post intervention.Wright medical group's medical director contacted dr.(b)(6), and obtained the following additional information: the patient is diabetic and obese; the surgical procedure performed on (b)(6) 2015 was a triple arthrodesis and to date, all joints look as though they have or are healing well; no clinical signs of infection - fluid obtained from the wound was serous without purulence; no hardware was removed during the incision and drainage; the wound was described as healing but not currently healed, and the patient was described as otherwise doing well; the surgeons's only concern was the drainage of serous fluid and his concern as to whether the serous drainage was related to the implant (augment); the surgeon did not have an opinion as to whether or not it was related to augment bone graft but only wondered if that had been seen in other patients.A quality investigation was performed with the report completed on 1/27/2016, based on record review and retain sample evaluation only since the product was completely consumed during the surgery and therefore product was not available to be returned.The conclusion of the investigation was as follows: since the product was not returned, the investigation was limited and the non-specific quality complaint could not be confirmed.The complaint history for augment bone graft indicates no previous history of complaints of this nature.Records including manufacturing records and any deviations were reviewed for this product lot, and revealed that there were no quality concerns during production or at release for this lot.The retain samples and lot release records were evaluated, and the retains showed no quality concerns and the product met all approved specifications at release.Stability studies for this lot have passed all stability testing at intervals up to and including shelf life of 3 years.No further information is available or anticipated.Awareness date of intervention to prevent serious injury: 01/05/2016.

• Brand Name: AUGMENT BONE GRAFT
• Type of Device: RH-PDGF AND BETA-TCP-BB COMBINATION DRUG DEVICE PRODUCT
• Manufacturer (Section D): BIOMIMETIC THERAPEUTICS LLC, SUBSIDIARY OF WRIGHT; 389 nichol mill ln.; fraanklin TN 37067
• Manufacturer (Section G): BIOMIMETIC THERAPEUTICS LLC; 389 nichol mill ln.; franklin TN 37067
• Manufacturer Contact: jeanne warner ; 389 nichol mill ln.; franklin, TN 37067 ; 6162834178
• MDR Report Key: 5498351
• MDR Text Key: 40250001
• Report Number: 3003897776-2016-00001
• Device Sequence Number: 1
• Product Code: NOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• 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: K20003010
• Device Lot Number: 5/31/17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/05/2016
• Device Age: 17 MO
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT SPECIFIED
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR