MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA OPTION CERAMIC HEAD 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number N/A

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

Patient Problem Impaired Healing (2378)

Event Date 04/08/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: bone screw self-tapping 6.5 mm dia.30 mm length, item# 00625006530, lot# j7181571 g7 longevity neutral 36mm e, item# 20103605, lot# 65255964 echo por fmrl lat nc, item# 192111, lot# 190070 g7 pps ltd acet shell 52e, item# 010000663, lot# 6881431 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.

Event Description

It was reported a patient underwent an initial left total hip arthroplasty nearly two years ago and subsequently, approximately two weeks later, developed erythema at the medial aspect of the left hip incision and was prescribed oral medication for two weeks and was resolved without complications.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.It is expected that a wound heals in stages and should be of normal appearance related to the timeframe since the incision was made.A surgical wound should be well approximated without redness, warmth, swelling and/or purulent drainage for the duration of its healing.The expression wound concerns or non-healing wound would imply that the appearance of the wound deviates from what a surgical wound should appear.It may be red, have drainage, additional pain, warmth and swelling as well as healing time may be delayed.This deviation signifies an alteration in the wound healing process which can be complicated by patient comorbidities such as diabetes, obesity, smoking, and other conditions that are known to slow a person¿s ability to heal.Wound complications can be treated conservatively or with prophylactic oral antibiotics to prevent further complications.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.Updated,.

• Brand Name: BIOLOX DELTA OPTION CERAMIC HEAD 36MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: 18911428
• MDR Text Key: 337736351
• Report Number: 3002806535-2024-00088
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271397
• UDI-Public: (01)00887868271397(17)310330(10)3063479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

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: 3063479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• 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
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Race: White