MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOXDELTAMODULARCERAMICHEAD 32MM-4MMNECK TYPE12/14TAPER; CERAMIC FEMORAL HEAD PROSTHESIS

Model Number N/A

Device Problem Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2 ¿ foreign ¿ germany.The product was returned for evaluation which identified that the reported mark is visually comparable to what is normally seen as metal transfer.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Medical records were not provided.The root cause of the reported issue is attributed to use error.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 during impaction, a cosmetic defect was observed on the surface of the ceramic head.The surgeon exchanged the head for a new one.No health consequences to the patient were reported.Attempts have been made and no further information has been provided.

• Brand Name: BIOLOXDELTAMODULARCERAMICHEAD 32MM-4MMNECK TYPE12/14TAPER
• Type of Device: CERAMIC FEMORAL HEAD 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: 18130008
• MDR Text Key: 328029563
• Report Number: 3002806535-2023-00386
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 05019279116928
• UDI-Public: (01)05019279116928(17)330302(10)3149951
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-0836
• Device Lot Number: 3149951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 140 KG