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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PH3 CEMENTLES FEM SZ XL; OXFORD CEMENTLESS FEMORALS

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BIOMET UK LTD. OXFORD PH3 CEMENTLES FEM SZ XL; 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 Date 08/24/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Concomitant medical products: customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00366 and 3002806535-2021-00368.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to pain in the lateral component was performed on (b)(6) 2021.Drs assessment was he may have "overstuffed" the medial compartment.
 
Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: as the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with any supporting documentation which could provide additional information.X-ray review could not be performed due to low quality images.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 1 complaint reported with the item 159561,1 complaint reported with the item 154928 and 2 complaints reported with the item 166576 (including the initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00366-1, 3002806535-2021-00368-1.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 a patient underwent an initial left knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to pain in the lateral component was performed on (b)(6) 2021.Drs assessment was he may have overstuffed the medial compartment.
 
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Brand Name
OXFORD PH3 CEMENTLES FEM SZ XL
Type of Device
OXFORD CEMENTLESS FEMORALS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key12405616
MDR Text Key269417957
Report Number3002806535-2021-00367
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
PMA/PMN Number
P010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/14/2021
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 Model NumberN/A
Device Catalogue Number154928
Device Lot Number3871099
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/24/2021
Initial Date FDA Received09/01/2021
Supplement Dates Manufacturer Received10/14/2021
Supplement Dates FDA Received10/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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