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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).0 degree face angle 36mm i.D.Cemented revision shell liner use with 58mm o.D.Shell, item# 00710505836, lot# 64025047.36mm cocr mod hd +9mm, item# 11-363665, lot# 176010.Hip mold stem w/reinf 9x200, item# 431195, lot# 712120.Optivac m, item# 4160, lot# 0001289908.G2 - australia.No product was returned or pictures provided; visual evaluation could not be performed.A review of the device manufacturing records could not be performed due to missing lot number.Radiographs were provided and reviewed by a radiologist.The review identified a left total hip arthroplasty with fractured proximal femoral component.Possible cement fracture along the greater trochanter.Medical records were provided and reviewed by a health care professional.The review identified chronic left hip pain and previous revisions due to infection as contributing factor of the event.In the worst case approach, considering that a cement pack refobacin bone cement has been implanted to the patient as spacer during first-step surgery, this would be a user error as it is not an indicated use of the product.Indeed, as per instruction for use it is stated in the indications section that refobacin bone cements must be used for stable anchoring of suitable joint prostheses in primary operations, with added protection against infection, and also in revision operations resulting from aseptic loosening of the prosthesis and infection of the prosthesis by gentamicin sensitive strains.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.H3 other text : item and lot numbers unknown.

Event Description

It was reported that a patient underwent an initial left hip arthroplasty with unknown products sixteen years ago.Subsequently, the patient underwent revision due to periprosthetic infection six years ago and a washout a year later, all with unknown products.The patient had a spacer exchange with zimmer biomet implants approximately four and a half years ago.The patient was again revised approximately four and a half months ago due to pain.All records and implants previously reviewed.Implant fracture (spacer mold) was confirmed with possible cement fracture along the greater trochanter.It was reported that no further information is available.

• Brand Name: BIOMET UNKNOWN REFOBACIN BONE CEMENT R
• Type of Device: BONE CEMENT
• 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: 19048837
• MDR Text Key: 339430470
• Report Number: 3006946279-2024-00016
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• 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: CEMENT PACK RPBC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2023
• 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): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 74 KG