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 Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

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 ss ø48mm; item: p0463048; lot: 0001105980 (investigated in (b)(4)).Avantage inlay s48 / 22,2; item: p0560048; lot: 0001102705 (investigated in (b)(4)).Optipac-s 60 refobacin bone cement r item: 4711500396-1 lot: b708c06355 (investigated in (b)(4)).Femoral stem 12/14 item: 00811400100; lot: 63735436 (investigated in (b)(4)).Femoral head sterile 12/14 item: 00801802230 and lot: 63677745 (investigated in (b)(4)).Intramedullary plug item 02994000 / lot 172102309 (not a zimmer biomet product).The device was not returned to the manufacturer.Therefore it could not be analyzed no further information provided (x-rays, surgical report, photographs, lab test).The reported event could not be confirmed.The review of the device manufacturing quality record indicates that 926 products optipac-s 60 refobacin bone cement r, reference (b)(4), lot number a710b05615 were manufactured on date 16 march 2017.The device manufacturing quality record indicates 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.No non conformity or deviation was observed which could be linked to the event described in the complaint.No other similar complaint has been recorded for optipac-s 60 refobacin bone cement r, reference (b)(4), lot number a710b05615 on the reported event within one year.With the available information, the exact root cause of the event could not 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 an initial left total hip arthroplasty was performed on (b)(6) 2017 due to left femoral neck fracture.Avantage cemented shell, avantage inlay, optipac-s 60 refobacin bone cement, femoral stem, femoral head sterile and intramedullary plug were implanted.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.Wound complication lasted until mid-february as per patient.This event is investigated in the current complaint for the product optipac-s 60 refobacin bone cement lot a710b05615.Subsequently, the patient was revised on (b)(6) 2018 due to recurrent dislocations, instability, and impingement (investigated in (b)(4)).On (b)(6) 2018, the patient underwent a stage 1 revision of all components with implantation of an antibiotic spacer due to femoral periprosthetic fracture and concurrent infection (investigated in (b)(4)).The spacer was removed during the stage 2 revision on (b)(6) 2019.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
• 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: 9486452
• MDR Text Key: 172203295
• Report Number: 3006946279-2019-00542
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 03599870112229
• UDI-Public: (01)03599870112229
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K150850
• 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
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 4711500396-1
• Device Lot Number: A710B05615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2017
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 57