MAUDE Adverse Event Report: ETEX CORPORATION GAMMA BSM; BONE VOID FILLER, CALCIUM COMPOUND

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problem Unspecified Infection (1930)

Event Date 03/08/2018

Event Type  Injury  

Manufacturer Narrative

The product was removed and discarded and can not be returned to zimmer etex for investigation.If any additional information is received which would change or alter any conclusions or information, a supplemental will be filed accordingly.Device removed and disposed of.

Event Description

It was reported that a patient with a giant cell tumor underwent a procedure on (b)(6) 2018 to fill a tibia lesion.During the procedure five kits of gamma-bsm (four 10 cc and one 5 cc) were prepared in two separate batches by two different individuals due to the amount of product required causing a surgical delay of 30 to 45 minutes.The patient further underwent a revision procedure on (b)(6) 2018 due to infection.Upon removal it was noted that the outside was hard: however the inside was milky.

• Brand Name: GAMMA BSM
• Type of Device: BONE VOID FILLER, CALCIUM COMPOUND
• Manufacturer (Section D): ETEX CORPORATION; 38 sidney street; third floor; cambridge MA 02139
• Manufacturer (Section G): ETEX CORPORATION; 38 sidney street; third floor; cambridge MA 02139
• Manufacturer Contact: bosiljka kuhtreiber ; 38 sidney street; third floor; cambridge, MA 02139 ; 6175835591
• MDR Report Key: 7482092
• MDR Text Key: 107189983
• Report Number: 0001225112-2018-00002
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• PMA/PMN Number: PK101557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 76-6010 AND 76-6005
• Device Lot Number: 101884 AND 102077
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2016
• 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: 30 YR
• Patient Weight: 91