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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 5 PMA; KNEE PROSTHESIS
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BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 5 PMA; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384)
Patient Problems Pain (1994); Swelling (2091); Discomfort (2330)
Event Date 12/27/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, because the device it has been discarded.Concomitant medical products: medical product: oxford uni femoral sm, catalog #: 154600, lot #: 2158199, medical product: oxf uni tib tray sz c rm pma, catalog #: 154723, lot #: 2126442, medical product: cobalt g-hv bone cement 40g, catalog #: 402283, lot #: 526140.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00037, 3002806535-2020-00038.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device is discarded.
 
Event Description
It was reported that a patient underwent an initial right knee arthroplasty.Subsequently, the patient experienced swelling, pain, catching and grinding.An arthroscopy identified that the femoral component was grossly loose and the tibial poly was barely constrained in the femoral joint, therefore, a total revision procedure was performed.
 
Manufacturer Narrative
(b)(4).D10: customer has indicated that the product will not be returned to zimmer biomet for investigation, because the device it has been discarded.D11: medical product: oxford uni femoral sm, catalog #: 154600, lot #: 2158199.Medical product: oxf uni tib tray sz c rm pma, catalog #: 154723, lot #: 2126442.Medical product: cobalt g-hv bone cement 40g, catalog #: 402283, lot #: 526140.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00037-1, 3002806535-2020-00038-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.Four pre-revision radiographs (taken on (b)(6) 2019) were provided for analysis with (b)(4): two bilateral anteroposterior xrays (one of which is inverted horizontally); one mediolateral; and one skyline view.An accurate assessment of implant sizing and positioning cannot be made due to the poor quality of the images.Nonetheless, the femoral component is clearly loose in the ap x-rays.The anatomical bearing appears adequately positioned between the two articulating surfaces in one of the ap x-rays.Notes from the primary surgery ((b)(6) 2010) were not provided.Notes from a follow-up visit ((b)(6) 2019) state that the patient was a 63-year old female and had a bmi of 28.53 (overweight).The patient presented anterior and posterior swelling, as well as pain in flexion.All labs were negative for inflammatory markers, crp and elevated esr; white blood cell count was normal.The physician noted a jump and pop in the patellofemoral joint, patellofemoral crepitus through active flexion, and laxity in the medial collateral ligament.The patient then received a right knee arthroscopy, where implant loosening was identified.The zper states that the surgical technique was followed, and that the medical professional did not allege a deficiency in the performance of the device.The zper also states that cementless fixation was used, however cemented implants were used and bone cement is visible below the tibial tray.The presence of cystic and fibrotic tissue in the femur and the tibia was reported in the surgical notes from the revision procedure.This finding and the fact that stemmed components were chosen during revision are indicative of deteriorated bone stock quality.It is not possible to determine the cause of implant loosening without primary surgical notes and post-primary x-rays to assess initial implant sizing and positioning.The manufacturing history records (mhrs) for the oxford partial knee femoral component, tibial tray and anatomical bearing have been checked and verify that the components were manufactured and sterilised in accordance with the applicable specifications.We have not been provided with any supporting documentation which could provide additional information.A review of the complaint database over the last 3 years has found 1 similar complaints reported with the item 154723 and no similar complaints reported with these items 159570 and 154600.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported that a patient underwent an initial right knee arthroplasty.Subsequently, the patient experienced swelling, pain, catching and grinding.An arthroscopy identified that the femoral component was grossly loose and the tibial poly was barely constrained in the femoral joint, therefore, a total revision procedure was performed.
 
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Brand Name
OXF ANAT BRG RT SM SIZE 5 PMA
Type of Device
KNEE PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key9626570
MDR Text Key176213693
Report Number3002806535-2020-00039
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,health
Type of Report Initial,Followup
Report Date 03/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/30/2015
Device Model NumberN/A
Device Catalogue Number159570
Device Lot Number2018230
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/26/2020
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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