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

Catalog Number 4710500394-1

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

Patient Problems Bacterial Infection (1735); Failure of Implant (1924); Pain (1994); Osteopenia/ Osteoporosis (2651)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).List of associated devices: femoral component option size e right, reference (b)(4), batch 63957962; articular surface regular constraint, reference (b)(4), batch 63952346; poly patella standard size 35 mm diameter 9.0 mm thickness cemented, reference (b)(4), batch 63984274; stemmed nonaugmentable tibial component option cr/ps/lps size 5 for cemented use only, reference (b)(4), batch 63905965; optipac 40 refobacin bone cement r, reference (b)(4), batch a720a04010.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 a study patient underwent a right total knee arthroplasty on (b)(6) 2018.Subsequently, tibial baseplate loosening was noted on (b)(6) 2020 and the patient was revised on (b)(6) 2020.

Event Description

It was reported that a study patient underwent a right total knee arthroplasty on (b)(6) 2018.Subsequently, the patient underwent a stage 1 revision due to infection on (b)(6) 2020.All components were noted to be loose and easily removed, antibiotic infused cement spacers were placed.

Manufacturer Narrative

(b)(4).This follow-up report is being filled to relay additional information.Received x-ray shows that all components of the knee prosthesis are loosen as mentioned in the op notes.Therefore, the reported event has been confirmed.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.Medical records were translated in and it was found that the revision surgery was due to an infection.A lab analysis of the samples taken during the revision surgery has been performed and showed that the infection was due to staphylococcus epidermidis that is a normal colonizer of the skin and sometimes mucosa.It was also found that 6 of 12 blood samples dated from (b)(6) 2019 were positive to s.Epidermidis whereas the results were negative in (b)(6) 2020.The bacterial infection is the cause of the implant loosening and the revision.A complaint extract was done regarding revision due to infection, loosening and pain: 3 complaints (3 products), this one included, have been recorded on optipac 40 refobacin bone cement r, reference (b)(4), from (b)(6) 2017 to (b)(6) 2020.1 complaint (1 product), this one included, has been recorded on optipac 40 refobacin bone cement r, reference (b)(4), batch a744b05300.According to available data, root cause of the event was unable to be determined.Indeed, even if the implant loosening was due to the staphylococcus epidermidis bacterial infection, it is impossible to determine the root cause of the infection.The patient blood analysis showed that the bacterial germ was present in his blood in (b)(6) 2019, but the septicaemia could have occurred for several reason.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 40 REFOBACIN BONE CEMENT R
• Type of Device: BONE CEMENT, ANTIBIOTICS
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 10552488
• MDR Text Key: 207508402
• Report Number: 3006946279-2020-00184
• 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,study
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 4710500394-1
• Device Lot Number: A744B05300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASSOCIATED PRODUCTS LISTED IN H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 85