MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. ENDOBON XENOGRAFT GRANULES 2.0ML; BONE GRAFTING MATERIAL, SYNTHETIC

Model Number	ROX20
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Debris, Bone Shedding (1803); Edema (1820); Unspecified Infection (1930); Inflammation (1932); Pain (1994)
Date of Event	06/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source, foreign; event occurred in (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicates that (b)(4) products designation endobon xenograft granules 2.0ml, reference (b)(4), lot number w0075265 were manufactured on 19 september 2016.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.The review of the sterilization certificate indicates that the products were sterilized according to the specification.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent bone graft surgery on (b)(6) 2017.On (b)(6) 2017 bone exposure and healing delay was reported.On (b)(6) 2018 implant (competitor implant) had cutaneous abcess that is localized collection of pus in the skin.Implant remains implanted.As a result of the event patient had bone loss, healing delay, edema, hyperesthesia, infection, inflammation , pain and bone exposure.Patient would need to come back to medical office to open a flap for exploration and to perform a new bone graft with membrane.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).The following sections were updated: g1, g4, g5, h2, h6, h10.The device was not returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicates that 521 products designation endobon xenograft granules 2.0ml, reference rox20, lot number w0075265 were manufactured on 19 september 2016.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.The review of the sterilization certificate indicates that the products were sterilized according to the specification.Within one year, only the current complaint has been registered regarding pain, inflammation, infection and revision for endobon® xenograft granules.According to available data, the exact root cause can¿t 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 or Problem Description
It was reported that the patient underwent bone graft surgery on (b)(6), 2017.On (b)(6), 2017 bone exposure and healing delay was reported.On (b)(6) 2018 implant (competitor implant) had cutaneous abcess that is localized collection of pus in the skin.Implant remains implanted.As a result of the event patient had bone loss, healing delay, edema, hyperesthesia, infection, inflammation , pain and bone exposure.Patient would need to come back to medical office to open a flap for exploration and to perform a new bone graft with membrane.No additional patient consequences were reported.

• Brand Name: ENDOBON XENOGRAFT GRANULES 2.0ML
• Common Device Name: 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: 9294994
• Report Number: 3006946279-2019-00475
• Device Sequence Number: 11390152
• Product Code: LYC
• UDI-Device Identifier: 03599870091272
• UDI-Public: 03599870091272
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2018
• Device Model Number: ROX20
• Device Catalogue Number: ROX20
• Device Lot Number: W0075265
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR