MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 40 REFOBACIN BONE CEMENT R-3; BONE CEMENT, ANTIBIOTIC

Catalog Number 4710500394-3

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2022

Event Type  malfunction  

Manufacturer Narrative

This is a combination product (b)(4).Report source, foreign - event occurred in (b)(6).The device manufacturing quality record indicate that the released product met all requirements to perform as intended.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 that during hip artroplasty, a cement cup was implanted.A first attempt was made, but the cement did not bond with the acetabulum.The acetabular cup together with the cement tipped out of the acetabulum.A second attempt was made with another cement batch, the cement did not bond with the acetabulum, and the implant again tilted out of the acetabulum.Eventually, a cementless cup was implanted.The events result in a 45 minutes delay in procedure.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated: b4, g3, g6, h2, h3, h6, h10.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.Complaint history identified no additional complaints for the reported part/lot combination.A definitive root cause cannot be determined.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions.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 during hip artroplasty, a cement cup was implanted.A first attempt was made, but the cement did not bond with the acetabulum.The acetabular cup together with the cement tipped out of the acetabulum.A second attempt was made with another cement batch, the cement did not bond with the acetabulum, and the implant again tilted out of the acetabulum.Eventually, a cementless cup was implanted.The events result in a 45 minutes delay in procedure.No adverse events have been reported as a result of the malfunction.

• Brand Name: OPTIPAC 40 REFOBACIN BONE CEMENT R-3
• 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: 13720010
• MDR Text Key: 289606250
• Report Number: 3006946279-2022-00024
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 4710500394-3
• Device Lot Number: AZ45CI2815
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 80 KG