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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN PEG CMNTLS FMRL MD; OXFORD CEMENTLESS FEMORALS

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BIOMET UK LTD. OXF TWIN PEG CMNTLS FMRL MD; OXFORD CEMENTLESS FEMORALS Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00445, 3002806535-2021-00447.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.
 
Event Description
It was reported that the patient was seen in clinic on (b)(6) 2021 complaining of pain on her right pes anserinus bursa site.This issue was first noted on (b)(6) 2019 and was reported in (b)(4).Per visit note from (b)(6) 2021, implant is in good position, there were no evidence of fracture/lysis/wear/subsidence.Patient was prescribed nsaids and will be seen for a follow-up on (b)(6) 2021.
 
Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: no product was returned; visual and dimensional evaluations could not be performed.This device is used for treatment.No compatibility issues were noted.Device history record (dhr) review was unable to be performed as item #161474, lot #2409869 is missing and listed in capa ca-03772 missing mhrs.Review of the device history records for item #159575, lot #533550 and item #us166575, lot #3050471 identified no related deviations or anomalies during manufacturing related to the reported event.A review of the complaints database for 3 years prior to the notification date has identified the following: (6) similar complaints for item #159575 (including initiating complaint).There were (0) additional complaints against the lot #533550.(2) similar complaints for item #161474 (including initiating complaint).There were (0) additional complaints against the lot #2409869.(1) similar complaints for item #us166575 (including initiating complaint).There were (0) additional complaints against the lot #3050471.The clinical study patient was seen on (b)(6) 2021 complaining of pain on her right pes anserinus bursa site.This issue was first noted on aug 09, 2019 and was reported in (b)(4).In the radiographs from the 5-year follow-up the fit and position of all components appear to be adequate in accordance with the guidelines in the oxford surgical technique.Per visit note from (b)(6) 2021, implant is in good position, there were no evidence of fracture/lysis/wear/subsidence.Patient was prescribed treatment.The root cause of the reported adverse event could not be determined with the available information.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any additional information becomes available, then the complaint will be reopened and further investigated.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2021-00445-1 3002806535-2021-00447-1 if any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported, that: patient was seen in clinic on (b)(6) 2021 complaining of pain on her right pes anserinus bursa site.This issue was first noted on (b)(6) 2019 and was reported in (b)(4).Per visit note from (b)(6) 2021, implant is in good position, there were no evidence of fracture/lysis/wear/subsidence.Patient was prescribed nsaids and will be seen for a follow-up on (b)(6) 2021.Addi (b)(6) 2021: please see attached the radiographs available prior to the 5 year visit.
 
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Brand Name
OXF TWIN PEG CMNTLS FMRL MD
Type of Device
OXFORD CEMENTLESS FEMORALS
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 Key12638098
MDR Text Key276558231
Report Number3002806535-2021-00446
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Study,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/07/2022
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 Health Professional
Device Expiration Date06/16/2021
Device Model NumberN/A
Device Catalogue Number161474
Device Lot Number2409869
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/08/2021
Initial Date FDA Received10/15/2021
Supplement Dates Manufacturer Received01/07/2022
Supplement Dates FDA Received01/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2011
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) Other;
Patient Age76 YR
Patient Weight76 KG
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