MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 36MM; HIP PROSTHESIS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Cellulitis (1768); Unspecified Infection (1930); Pain (1994); Seroma (2069); Swelling/ Edema (4577)

Event Date 03/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product:g7 neutral e1 liner 36mm d, catalog #: 010000856, lot #:6383738, medical product: g7 osseoti 3 hole shell 50mm d, catalog #: 110010243, lot #: 6378467, medical product:echo b-mtrc mp fp ho 9, catalog #:193109, lot #: 089870.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-01635.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

It was reported that the patient had a femoral head and acetabular liner exchange 6 weeks post initial total hip arthroplasty due to a superficial seroma infection.

Event Description

It was reported that the patient had a femoral head and acetabular liner exchange 6 weeks post initial total hip arthroplasty due to a superficial seroma infection.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.D10: associated products: item name: cer option type 1 tpr sleve -6, item number: 650-1064, lot number: 2950539.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.Devices are used for treatment.Medical records were provided and reviewed.26 images assessed but not sent to mmi as revision is due to infection which would not be visible on x-ray.Sending the images would not enhance the investigation.The patient had a superficial infected seroma that was between the tensor fascia lata muscle and sartorius.There was no deep communicating sinus into the hip joint.Hip capsule was intact.Surgeon aspirated the hip and it was dry with a few drops of blood.Surgeon elected to incise the capsule which was totally healed.The joint itself was totally dry.There was no purulence noted throughout the hip joint.The patient developed acute left buttock and lateral hip pain and cellulitis.Initial inflammatory markers were normal with elevated wbc.Anterior fluid collected aspirated and found to be purulent.Hip joint aspiration was dry.No surgical complications were noted, patient has a history of a right toe mrsa infection and right lower leg cellulitis.This places her at higher risk of developing her reported condition.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

It was reported that patient underwent revision of left total hip arthroplasty approximately three (3) weeks later initial surgery to superficial seroma infection.The acetabular liner, head, and sleeve were exchanged although no communication into the joint space was encountered.Intraop cultures grew group b strep.Six days post operatively patient had cellulitis, pain, erythema, and swelling.The patient was instructed to continue with the prescribed medication regimen and it resolved two weeks later.No further event information available at the time of this report.

• Brand Name: CER BIOLOXD OPTION HD 36MM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8548659
• MDR Text Key: 143026669
• Report Number: 3002806535-2019-00409
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00880304521957
• UDI-Public: (01)00880304521957(17)280903(10)2948097
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2023

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 650-1057
• Device Lot Number: 2948097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 09/17/2019; 05/18/2023
• Supplement Dates FDA Received: 09/17/2019; 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2018
• 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: SEE H10.; SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: White