MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC-S 60 REFOBACIN BONE CEMENT R; BONE CEMENT, ANTIBIOTIC

Catalog Number 4711500396-1

Device Problems Microbial Contamination of Device (2303); Patient Device Interaction Problem (4001)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 12/01/2020

Event Type  Injury  

Event Description

It was reported through a clinical study that a patient underwent a primary total knee arthroplasty on (b)(6) 2019.Subsequently, the patient was revised on (b)(6) 2020 date due to deep infection.

Manufacturer Narrative

This is a combination product: (b)(4).List of associated devices: psn asf cr 10mm ply l 3-11 ef, reference 42-5110-005-10, batch 63535021; psn tib stm 5 deg sz f l, reference 42-5320-075-01, batch 63560762; psn fem cr cmt ccr std sz 11 l, reference 42-5026-070-01, batch 63567263; psn all poly pat ply 38mm, reference 42-5400-000-38, batch 64100059.Report source, foreign - event occurred in (b)(6).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.

Manufacturer Narrative

This is a combination product: (b)(4).List of associated devices: psn asf cr 10mm ply l 3-11 ef, reference 42-5110-005-10, batch 63535021; psn tib stm 5 deg sz f l, reference 42-5320-075-01, batch 63560762; psn fem cr cmt ccr std sz 11 l, reference 42-5026-070-01, batch 63567263; psn all poly pat ply 38mm, reference 42-5400-000-38, batch 64100059.Report source, foreign - event occurred in (b)(6).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 Description

It was reported through a clinical study that a patient underwent a primary total knee arthroplasty on (b)(6) 2019.Subsequently, the patient was revised on (b)(6) 2020 date due to deep infection.

Event Description

It was reported through a clinical study that a patient underwent a primary total knee arthroplasty on (b)(6) 2019.Subsequently, the patient was revised on (b)(6) 2020 date due to deep infection.The patient went to the emergency room due to swelling of the knee after heavy work, pain in the medial compartment was observed and it was not possible to examine the stability of the knee, after a knee puncture staphylococcus lugdunensis were detected, due to this revision in two stages was performed.All bone attached components were well placed and the insert did not have any wear.

Manufacturer Narrative

This is a combination product (b)(4).This follow-up report is being submitted to relay additional information.The review of the medical records by the hospital showed that the infection was due to staphylococcus lugdunensis and is a commensal bacteria on human skin.The product analysis can't be performed as the product was not returned.The device manufacturing quality record indicate 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.A complaint extract was done regarding revision due to infection: 5 complaints (5 products), this one included, have been recorded on optipac 60 refobacin bone cement r-1, reference (b)(4), from (b)(6), 2019 to (b)(6), 2022.1 complaint (1 product), this one included, has been recorded on optipac 60 refobacin bone cement r-1, reference (b)(4), batch a747c07115.According to available data, root cause of the event was unable to be determined.However, 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.

• Brand Name: OPTIPAC-S 60 REFOBACIN BONE CEMENT R
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13382068
• MDR Text Key: 285931662
• Report Number: 3006946279-2022-00009
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 4711500396-1
• Device Lot Number: A747C07115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2018
• 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
• Treatment: ASSOCIATED DEVICES LISTED IN H10.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male