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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE 2 8 MM; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE 2 8 MM; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Naturally Worn (2988); Migration (4003)
Patient Problems Pain (1994); Swelling (2091)
Event Date 05/26/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: item (b)(4), lot: 63777152; item (b)(4), lot: 63563611.Foreign (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient received a total knee arthroplasty and approximately one year after the procedure the patient experienced pain and swelling and was revised two years after the initial procedure due to dislodge and poly wear.Attempts have been made and no further information has been received.
 
Event Description
It was reported that the patient received a total knee arthroplasty and approximately one year after the procedure the patient experienced pain and swelling and was revised two years after the initial procedure due to dislodge and poly wear.It was noted significant findings of a compartmental arthroplasty with joint space loss of the medial compartment and inferior depression of the tibial.Attempts have been made and no further information has been received.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02001.
 
Manufacturer Narrative
(b)(4).Visual evaluation of the returned products found the articular surface to exhibit damage in the proximal and distal surfaces (nicked / gouged / wear / discoloration) and the locking features.Visual examination of the returned product confirmed implant wear.Unable to confirm articular surface disassociation.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.X-rays were provided and reviewed by a health care professional.Review found joint space loss of the medial compartment and inferior depression of the tibial plateau component (subsidence), resulting in genu varus.Overall bone quality appears normal.A definitive root cause cannot be determined.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
No further event information available at the time of this report.
 
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Brand Name
ARTICULAR SURFACE SIZE 2 8 MM
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10128746
MDR Text Key194368733
Report Number0001822565-2020-02002
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
PMA/PMN Number
K033363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 09/03/2020
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 Date05/31/2024
Device Model NumberN/A
Device Catalogue Number00584202208
Device Lot Number63355036
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/26/2020
Initial Date FDA Received06/08/2020
Supplement Dates Manufacturer Received06/10/2020
08/31/2020
Supplement Dates FDA Received06/17/2020
09/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age63 YR
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