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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)

Patient Problems Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060)

Event Date 02/08/2022

Event Type  Injury  

Event Description

It was reported that patient underwent revision surgery due to the pain, limited rom, stiffness, scar tissue and adhesions about two (2) years after initial surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Femur cemented cruciate retaining (cr) narrow right size 7, item# 42502006202, lot# 64672793; articular surface medial congruent (mc) right 13 mm height use with tibia sizes cd/ cr femur sizes 6-7, item# 42522100413, lot# 64461580; all-poly patella cemented 29 mm diameter, item# 42540200029, lot# 64775977; the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Device remains implanted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Device is used for treatment.Medical records/radiographs were provided and reviewed.The patient suffered from pain and loss of range of motion.He was revised in downsizing poly from a 13mm to a 12mm.The cement has not been removed.Eight months later, the patient goes stable with no pain.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN REFOBACIN BIOMET BONE CEMENT
• 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: 16618395
• MDR Text Key: 312109029
• Report Number: 3006946279-2023-00037
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 05/02/2023
• Supplement Dates FDA Received: 05/04/2023
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Race: White