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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

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BIOMET UK LTD. CER BIOLOXD OPTION HD 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 Problems Wound Dehiscence (1154); Bacterial Infection (1735); Impaired Healing (2378)
Event Date 07/05/2017
Event Type  Injury  
Event Description
It was reported that three weeks post implantation, the rehab facility reported that the incision areas were not closing properly.The patient underwent weekly wound debridement's to assist with closure and a bacterial infection was confirmed.The complication resolved 4 months postop.There is no additional information available at the time of this report.
 
Manufacturer Narrative
(b)(4).D10 ¿ medical devices: cer option type 1 tpr sleve -6; item# 650-1064; lot# 2897761.Tprlc 133 fp type1 pps so 15.0; item# 51-100150; lot# 2299334.G7 finned 4 hole shell 54f; item# 110017104; lot# 6038566.G7 neutral e1 liner 36mm f; item# 010000858; lot# 6033052.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00418.3002806535 - 2023 - 00419.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
No further event information available at the time of this report.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional 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 more invasively with an irrigation and debridement (i&d) which promotes healing at the site and prevents further complications.Superficial infections are considered a procedure related complication as no device has been reported as revised.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations, further eliminating the implanted devices as a potential source for the reported infection.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.As device has not been indicated as revised and there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.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.
 
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Brand Name
CER BIOLOXD OPTION HD 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 Key18289780
MDR Text Key329994453
Report Number3002806535-2023-00418
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200959
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/27/2023
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 NumberN/A
Device Catalogue Number650-1057
Device Lot Number2897727
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/16/2023
Initial Date FDA Received12/08/2023
Supplement Dates Manufacturer Received12/21/2023
Supplement Dates FDA Received12/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/25/2017
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) Hospitalization; Other;
Patient SexFemale
Patient Weight139 KG
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