MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC-S 80 REFOBACIN REVISION; BONE CEMENT, ANTIBIOTIC

Model Number N/A

Device Problem Improper Chemical Reaction (2952)

Patient Problem Failure of Implant (1924)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Please note that zfa 2017-500 did not affect usa.The investigation in ongoing.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient had a revision from a primary vanguard tkr to vanguard 360 on (b)(6) 2017.The cement used during this revision surgery on (b)(6) 2017 was affected by the zimmer biomet product recall zfa 2017-500.On (b)(6) 2019, the implants were removed and replaced with vanguard 360 revision implants.Pictures were taken of the removed implants and it was noted that the cement had failed to bond to the patient bone.All of the cement was removed completely intact around the implants.

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 investigation in ongoing.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that a patient had a revision from a primary vanguard tkr to vanguard 360 on the (b)(6) 2017.The cement used during this revision surgery on (b)(6) 2017 was affected by the zimmer biomet product recall zfa 2017-500.On (b)(6) 2019, the implants were removed and replaced with vanguard 360 revision implants.Pictures were taken of the removed implants and it was noted that the cement had failed to bond to the patient bone.All of the cement was removed completely intact around the implants.

Event Description

It was reported that a patient had a revision from a primary vanguard tkr to vanguard 360 on the (b)(6) 2017.The cement used during this revision surgery on (b)(6) 2017 was affected by the zimmer biomet product recall zfa 2017-500.On (b)(6) 2019, the implants were removed and replaced with vanguard 360 revision implants.Pictures were taken of the removed implants and it was noted that the cement had failed to bond to the patient bone.All of the cement was removed completely intact around the implants.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay correction information.The following section has been updated : b5,d10,g4, g7, h2, h3, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.X rays and surgical reports were not provided.The device was not returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicates that 737 products designation optipac-s 60 refobacin bone cement r, reference (b)(4), lot number a620a0178a were manufactured on 23 august 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.Only this complaint has been recorded for optipac-s 80 refobacin rev, batch a620a0178a within one year.Root cause was unable to be determined as the necessary information(product, xrays and medical records) to adequately investigate the reported event was not provided.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.

• Brand Name: OPTIPAC-S 80 REFOBACIN REVISION
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 8494751
• MDR Text Key: 141307141
• Report Number: 3006946279-2019-00220
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 03599870110379
• UDI-Public: (01)03599870110379
• Combination Product (y/n): N
• PMA/PMN Number: K150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 4732501165-1
• Device Lot Number: A620A0178A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 03/19/2019; 10/21/2019
• Supplement Dates FDA Received: 05/20/2019; 10/25/2019
• 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