MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. ENDOBON® XENOGRAFT GRANULES 0.5ML; BONE MATRIX IMPLANT, ANIMAL-DERIVED, NON-ABSORBABLE

Model Number N/A

Device Problem Failure to Osseointegrate (1863)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Inadequate Osseointegration (2646)

Event Date 04/27/2021

Event Type  Injury  

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 device manufacturing quality record indicates that the released product met all requirements to perform as intended.The review of the sterilization certificate indicates that the products were sterilized according to the specification.The review of the raw material certificate shows no non conformity or deviation.The label of the product is stuck on the zper and confirms the expiration date.Complaint history : a complaint extract was done regarding medical : infection and non integration: 12 complaints (12 products), this one included, have been recorded on endobon® xenograft granules 0.5ml, reference rox05, from 01 jan 2018 to 18 aug 2021.1 complaint (1 product), this one included, has been recorded on endobon® xenograft granules 0.5ml, reference rox05, batch y0098304.A complaint extract was done regarding medical : expired product implanted.1 complaint (1 product), this one included, has been recorded on endobon® xenograft granules 0.5ml, reference rox05, from 01 jan 2018 to 27 aug 2021.1 complaint (1 product), this one included, has been recorded on endobon® xenograft granules 0.5ml, reference rox05, batch y0098304.Investigation results concluded that the reported event was due to user error (the product has been used in spite of the expiration date passed).A summary of the investigation was sent to the complainant conveying proper use of the device.There is no evidence that the event is related to the product.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

It has been reported that the patient had a loss of integration and infection with pain and inflammation after a endobon xenograft implantation.Doctor performed reconstruction.

• Brand Name: ENDOBON® XENOGRAFT GRANULES 0.5ML
• Type of Device: BONE MATRIX IMPLANT, ANIMAL-DERIVED, NON-ABSORBABLE
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 12376477
• MDR Text Key: 268423428
• Report Number: 3006946279-2021-00139
• 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
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: ROX05
• Device Lot Number: Y0098304
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2018
• 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: 56 YR