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

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Inflammation (1932); Loss of Range of Motion (2032); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 06/22/2021

Event Type  Injury  

Manufacturer Narrative

This is a combination product.(b)(4).Report source, foreign - event occurred in (b)(6).No further information provided (x-rays, surgical report, photographs, lab test).The product analysis can't be performed as the product was not returned.Therefore, the reported event could not be confirmed.The review of the device manufacturing quality can't be performed as the product reference and batch number was not communicated.A complaint extract was done regarding revision due to pain, implant loosening and inflammation: (b)(4) complaints ((b)(4) products), this one included, have been recorded on optipac refobacin bone cement r, from (b)(6) 2018 to (b)(6) 2021.The complaint history, regarding the reference number, can't be performed as it was not communicated.The complaint history, regarding the batch number, can't be performed as it was not communicated.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.

Event Description

It was reported that the patient underwent an initial partial knee surgery on (b)(6) 2020, with optipac refobacin bone cement r was used during surgery.After that, the patient suffered from pain, swelling and progressive loss of range of motion of the knee.Despite medical treatment and physiotherapy, the pain persisted.On (b)(6) 2021, patient had an increased inflammation value (crp = 6 mg/ l).On (b)(6) 2021, patient underwent a revision surgery due to a suspicion of septic loosening.As reported, the operation report stated that there was practically no mechanical connection in the implant - cement interface - and that the implant could be easily retrieved.It was also reported that the femur component was no longer frictional connected.No issue was noticed during the revision surgery.No pathological examination of the tissue in the region of the prosthesis was performed.

• Brand Name: OPTIPAC REFOBACIN BONE CEMENT R
• Type of Device: BONE CEMENT, MEDICATED
• 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: 13026048
• MDR Text Key: 283958291
• Report Number: 3006946279-2021-00210
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: N/A
• 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: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNIVATION X FROM AESCULAPAG B BRAUN BRAND
• Patient Outcome(s): Required Intervention