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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Migration or Expulsion of Device (1395); Noise, Audible (3273)
Patient Problems Pain (1994); Swelling (2091); Weakness (2145); Numbness (2415); Limited Mobility Of The Implanted Joint (2671)
Event Date 01/30/2018
Event Type  Injury  
Manufacturer Narrative
Zimmer biomet complaint number (b)(4). Concomitant medical product: persona fixed bearing articular surface; p/n: 42512401014, l/n: 62199213; persona posterior stabilized femoral; p/n: 42500607001, l/n: 62629231; persona all polyethylene patella; p/n: 42540000038, l/n: 62113096. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown. 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: 3007963827 - 2019 - 00086, 0002648920 - 2019 - 00240. Product location is unknown.
 
Event Description
It was reported that the patient underwent a revision procedure four years post-implantation due to loosening. During the revision procedure, the surgeon noted lack of bony ingrowth and subsidence of the tibial component and bone cement present on device.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed. Visual evaluation of two-peg trabecular metal tibia, from the picture provided exhibits sign of being implanted with one peg was covered with soft tissues than other peg. Primary surgical notes was provided and found no complication noted. The x-ray was provided and review was performed by third party hcp. The review states loosening and radiolucency along tibia plate. Dhr was reviewed and no discrepancies relevant to the reported event were found. Investigation results concluded that the reported event was due to design deficiency. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 01302 - 3, 0001822565 - 2018 - 02467 - 1, 3007963827 - 2019 - 00086 - 1, 0002648920 - 2019 - 00240 - 1.
 
Event Description
No further event information available at the time of this report.
 
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Brand NameARTICULAR SURFACE FIXED BEARING
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8468988
MDR Text Key140440426
Report Number0001822565-2019-01316
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
PMA/PMN Number
K121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2017
Device Model NumberN/A
Device Catalogue Number42512401014
Device Lot Number62199213
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/01/2019 Patient Sequence Number: 1
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