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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Unspecified Infection (1930); Discharge (2225)

Event Date 01/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Concomitant medical products: avantage cemented shell s48, item: p0463048, lot: 0001105980; avantage inlay s48 / 22,2, item: p0560048, lot: 0001102705; optipac-s 60 refobacin bone cement r, item: 4711500396-1, lot: a710b05615; femoral stem 12/14, item: 00811400100; lot: 63735436; femoral head sterile 12/14, item: 00801802230, and lot: 63677745.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that an initial left total hip arthroplasty was performed with implantation of an avantage cemented shell ø48mm, avantage inlay s48, optipac-s 60 refobacin bone cement, femoral stem 12/14 and femoral head sterile 12/14 on (b)(6) 2017.Subsequently, the patient experienced redness and drainage from the surgical site, was placed on prophylactic antibiotics, and was admitted for observation to rule out infection.Infection was ruled out, and the drainage discontinued without further complication.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b5, g4, h10.During the investigation, it has been noticed that the product 4711500396-1 / lot b708c05355 is handled by (b)(4).The medwatch report for this product will be submitted in (b)(4).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 an initial left total hip arthroplasty was performed with implantation of an avantage cemented shell ø48mm, avantage inlay s48, optipac-s 60 refobacin bone cement, femoral stem (b)(6), femoral head sterile (b)(6) and intramedullary plug on (b)(6) 2017.Subsequently, the patient experienced redness and drainage from the surgical site, was placed on prophylactic antibiotics, and was admitted for observation to rule out infection.Infection was ruled out, and the drainage discontinued without further complication.No additional patient consequences were reported.

• 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
• MDR Report Key: 8951657
• MDR Text Key: 156778664
• Report Number: 3006946279-2019-00385
• Device Sequence Number: 1
• Product Code: MBB
• 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
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4711500396-1
• Device Lot Number: B708C05355
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2019
• 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
• Patient Weight: 57