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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL; PROSTHESIS, KNEE

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BIOMET UK LTD. OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395); Unstable (1667); Metal Shedding Debris (1804)
Patient Problems Pain (1994); Reaction (2414)
Event Date 11/07/2011
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products ¿ oxford anatomic bearing size 8 catalog 159580 lot 1195337; oxford tibial tray size d catalog 154725 lot 1278419.Customer has not indicated whether product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2017-00543, 3002806535-2017-00542.
 
Event Description
It was reported a patient underwent a revision procedure to convert from a right partial knee prosthesis to a total knee approximately seven years post implantation due to pain, wear, instability, and arthroplasty collapse with migration.The patient reportedly began experiencing pain and instability approximately three and a half years post-operatively, however no issues were found until the patient began experiencing worsening pain approximately seven years post-operatively.The femoral and tibial components were said to have been in contact with one another and were noted to have evidence of gross abrasive wear.The tibial bearing was also noted to evidence asymmetrical wear.
 
Manufacturer Narrative
This follow-up report is being filed to relay this report is a duplicate of 3002806535-2017-00283.
 
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Brand Name
OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL
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
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6686528
MDR Text Key79064939
Report Number3002806535-2017-00541
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PP010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 10/26/2017
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? Yes
Device Operator Health Professional
Device Expiration Date02/28/2018
Device Model NumberN/A
Device Catalogue Number154601
Device Lot Number1447847
Other Device ID NumberSEE H10 NARRATIVE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/31/2017
Initial Date FDA Received07/05/2017
Supplement Dates Manufacturer Received09/26/2017
Supplement Dates FDA Received10/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/20/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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