MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40; BONE CEMENT, ANTIBIOTICS

Catalog Number 110034355

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

Patient Problems Edema (1820); Pain (1994); Swelling (2091); Hip Fracture (2349); Ambulation Difficulties (2544); Osteopenia/ Osteoporosis (2651)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).List of associated devices: partial tibial cemented size d left medial, reference 42538000401, batch unknown, handle in (b)(4); partial femur cemented size 3 left medial, reference 42558000301, batch 64465213, handle in (b)(4); partial articular surface left medial size d 10 mm thickness, reference 42518200410, batch 63755573, handle in (b)(4).The device will not be returned to the manufacturer.Therefore it will not be analyzed.The device manufacturing quality record indicates 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 a patient had an initial unilateral total left knee arthroplasty on (b)(6) 2020.Subsequently, the patient fell approximately three weeks post-op.The patient began experiencing difficulty ambulating, decrease in adl¿s, pain, swelling, radiolucency, a periprosthetic fracture, loosening, subsidence, and poor bone quality.The patient was revised to a full total left knee arthroplasty on (b)(6) 2020.

Event Description

It was reported that a patient had an initial unilateral total left knee arthroplasty on (b)(6) 2020.Subsequently, the patient fell approximately three weeks post-op.The patient began experiencing difficulty ambulating, decrease in activities of daily living, pain, swelling, radiolucency, a periprosthetic fracture, loosening, subsidence, and poor bone quality.The patient was revised to a full total left knee arthroplasty on (b)(6) 2020.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g4, g7, h2, h6, h10.Received primary admission notes does not indicates any intra-op complication, especially during the cementing phase.The revision pre-op has also been reviewed and shows that the patient fall 3 weeks after the initial surgery.Since that fall, the patient underwent continued pain, swelling and difficulty to walk.Moreover, the x-ray were interpreted by the surgeon who stated that: left medial partial knee replacement with lucency across cement prosthetic interface and depression pf tibial component.Finally, the revision admission notes stated that the patient had a poor tibial bone quality and there was a fracture of the tibial bone.It is also mentioned that the cement mantle was intact there did not appear to be any complications with the hardware itself.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 instructions for use has been reviewed and it is stated that 'unanticipated postoperative event may affect the cement bone interface and lead to micro motion of cement against the bone surface.A fibrous tissue layer may develop between the cement and the bone, and loosening of the prosthesis may occur leading to implant failure.' a complaint extract was done regarding revision due to pain, loosening, and bone fracture: - 4 complaints (4 products), this one included, have been recorded on refobacin bone cement r 1x40 us, reference (b)(4) , from (b)(6) 2018 to (b)(6) 2021.- 1 complaint (1 product), this one included, has been recorded on refobacin bone cement r 1x40 us, reference (b)(4) , batch 835aae2507.According to available data, the most probable root cause of the event could be the patient condition, especially the patient fall three weeks after the initial surgery and the poor bone quality which could explain the bone fracture at the tibial level, the pain and the implant loosening.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: REFOBACIN BONE CEMENT R 1X40
• 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: 10625324
• MDR Text Key: 209764938
• Report Number: 3006946279-2020-00195
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 00880304990197
• UDI-Public: 0880304990197
• Combination Product (y/n): N
• PMA/PMN Number: K171540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 110034355
• Device Lot Number: 835AAE2507
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ASSOCIATED DEVICES LISTED IN H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 90