MAUDE Adverse Event Report: BIOCOMPOSITES LTD STIMULAN RAPID CURE

Model Number	620-010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discharge (2225)
Date of Event	05/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon presentation of the drainage 3-4 days post op the surgeon elected for immediate second op, repeat i & d was performed to remove the beads, no beads were present in the joint.This was the surgeon's first procedure using stimulan rapid cure, but is experienced with the procedure.Four days post op the patient is recovering well, no drainage and the wound is healing.The patient had been an inpatient for almost a month prior to his infected knee and the presence of (b)(6).Based on the information received, suspected root causes are: the use of antibiotics may have altered the characteristics of the product.The patient's infection remained, which may have contributed to the drainage.Sterile drainage is a known occurrence associated with calcium sulphate and other materials.Excess material implanted at the surgical site may also be a contributory factor.
Event or Problem Description
Physician reported to distributor a patient who experienced drainage 3-4 days post op after implantation of stimulan rapid cure 10cc, mixed with 1 gram vancomycin, drainage was not expected.

• Brand Name: STIMULAN RAPID CURE
• Common Device Name: STIMULAN RAPID CURE
• Manufacturer (Section D): BIOCOMPOSITES LTD; keele science park; keele, ST5 5 NL; UK ST5 5NL
• MDR Report Key: 6614399
• Report Number: 9617083-2017-00002
• Device Sequence Number: 507595
• Product Code: MQV
• UDI-Device Identifier: 50601557110348
• UDI-Public: 50601557110348
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K141830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 620-010
• Device Catalogue Number: 620-010
• Device Lot Number: 02/17-R318/319
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 06/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VANCOMYCIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR