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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING ARCOM LEFT MEDIAL MEDIUM 6M; PROSTHESIS, KNEE

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BIOMET UK LTD. OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING ARCOM LEFT MEDIAL MEDIUM 6M; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Off-Label Use (1494)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 09/27/2016
Event Type  Injury  
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly.(b)(4).
 
Event Description
During a right partial knee arthroplasty, a left meniscal bearing was implanted instead of a right.There was no discrepancy with the packaging or the implant.No additional information is known.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
 
Event Description
During a right partial knee arthroplasty, a left meniscal bearing was implanted instead of a right.There was no discrepancy with the packaging or the implant.There is no intervention planned as the patient has not experienced any complications.
 
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Brand Name
OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING ARCOM LEFT MEDIAL MEDIUM 6M
Type of Device
PROSTHESIS, KNEE
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
daniel tilbury
waterton industrial estates
bridgend 
0441656655
MDR Report Key6057528
MDR Text Key58399307
Report Number3002806535-2016-00799
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
PP010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/27/2016
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 Physician
Device Expiration Date11/30/2020
Device Model NumberN/A
Device Catalogue Number159550
Device Lot Number3693790
Other Device ID NumberSEE NARRATIVE IN H10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/27/2016
Initial Date FDA Received10/26/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/02/2015
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;
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