MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. CEMENT WITH GENTAMYCINE; BONE CEMENT, ANTIBIOTICS

Catalog Number NOT COMMUNICATED

Device Problem Insufficient Information (3190)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 08/14/2020

Event Type  Death  

Manufacturer Narrative

This is a combination product.(b)(4).Report source, foreign and study - event occurred in (b)(6).List of associated products : ps femoral porous, standard, size 9, right; ref : 42500806602 batch : 63111358; persona tibial base plate (right) size f; ref : 42532007502 batch : 63198951; persona ps conv (right) size 7, 10mm + thick; ref : 42521400710 batch : 63470553; persona all poly 35mm patella; ref : 42540000035 batch : 63426281.The device manufacturing quality record can't be done since the batch wasn't communicated.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.Reference - batch number wasn't shared.

Event Description

It was reported that a patient who was part of polar-total knee arthroplasty clinical study has died.The cause of death is due to massive brain hemorrhage.The exact dat of patient death is not known.

Manufacturer Narrative

This is a combination product (b)(4) the product analysis can't be performed as the product was not returned.The brand, reference or batch were not communicated.7 others complaint on patient death was recorded on cement pack and optipac, from (b)(6)2018 to (b)(6)2021.According to available data, root cause of the event was unable to 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

It was reported that a patient who was part of polar-total knee arthroplasty clinical study has died.The cause of death is due to massive brain hemorrhage.The exact date of patient death is not known.

• Brand Name: CEMENT WITH GENTAMYCINE
• Type of Device: BONE CEMENT, ANTIBIOTICS
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 11730385
• MDR Text Key: 247449468
• Report Number: 3006946279-2021-00073
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: NOT COMMUNICATED
• Device Lot Number: NOT COMMUNICATED
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE THE ASSOCIATED PRODUCTS IN H10.
• Patient Outcome(s): Death