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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 3 PMA; OXFORD HXLPE BEARINGS
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BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 3 PMA; OXFORD HXLPE BEARINGS Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Swelling/ Edema (4577)
Event Date 09/01/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Associated products: medical product: optipac rbc 40, catalog no.: unknown, lot no.: unknown.Multiple mdr reports were filed for this event, please see associated reports (add this for a multiple item complaint): 3002806535-2021-00337, 3002806535-2021-00338.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 knee arthroplasty on (b)(6) 2011.Subsequently, the surgeon reported minimal swelling of the ipsilateral knee after partial knee arthroplasty with a tinbn-coated implant which onset on (b)(6) 2019.Surgeon categorized the event as an adverse event, with uncertain relation to the device and probably related to the procedure.Patient was treated with icing the knee and conservative treatment.Swelling is now not persistent anymore.
 
Event Description
It was reported that a patient underwent an initial knee arthroplasty on (b)(6) 2011.Subsequently, the surgeon reported minimal swelling of the ipsilateral knee after partial knee arthroplasty with a tinbn-coated implant which onset on (b)(6) 2019.Surgeon categorized the event as an adverse event, with uncertain relation to the device and probably related to the procedure.Patient was treated with icing the knee and conservative treatment.Swelling is now not persistent anymore.
 
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 and complaint history.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records could not be performed as lot number is unknown.A review of the complaint database over the last 3 years has found 1 complaint reported with the item 154601tnbn, 154722tnbn and 159547 (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: 3002806535-2021-00337-1; 3002806535-2021-00338-1.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.H3 other text: device remains implanted.
 
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Brand Name
OXF ANAT BRG LT MD SIZE 3 PMA
Type of Device
OXFORD HXLPE BEARINGS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key12266974
MDR Text Key264932461
Report Number3002806535-2021-00339
Device Sequence Number1
Product Code NRA
UDI-Device Identifier05019279785933
UDI-Public05019279785933
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,study
Type of Report Initial,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number159547
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEEH10
Patient Outcome(s) Other;
Patient Age71 YR
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