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U.S. Department of Health and Human Services

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

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BIOMET UK LTD. BIOLOX DELTA OPTION CERAMIC HEAD 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER Back to Search Results
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,.
 
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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 Key18911428
MDR Text Key337736351
Report Number3002806535-2024-00088
Device Sequence Number1
Product Code LZO
UDI-Device Identifier00887868271397
UDI-Public(01)00887868271397(17)310330(10)3063479
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192683
Number of Events Reported1
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 NumberN/A
Device Catalogue Number650-1057
Device Lot Number3063479
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 Received03/15/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/19/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
Patient Weight74 KG
Patient RaceWhite
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