MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. ENDOBON XENOGRAFT GRANULES 0.5ML; BONE GRAFTING MATERIAL, SYNTHETIC

Model Number N/A

Device Problem Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Date 07/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned.

Event Description

It was reported that biomaterial was not integrated, so bone material was not compacted after placing the implant, resulting in implant failure.Biomaterial placed on (b)(6) 2017, implant placed on (b)(6) 2017 and non integration appeared on (b)(6) 2018.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.  the device was not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.According to the available data, the exact root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

Please refer to report 3006946279-2019-00042.

• Brand Name: ENDOBON XENOGRAFT GRANULES 0.5ML
• Type of Device: BONE GRAFTING MATERIAL, SYNTHETIC
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 8251940
• MDR Text Key: 133181770
• Report Number: 3006946279-2019-00042
• Device Sequence Number: 1
• Product Code: LYC
• UDI-Device Identifier: 03599870091258
• UDI-Public: 03599870091258
• Combination Product (y/n): N
• PMA/PMN Number: K110449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ROX05
• Device Lot Number: V044208B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention