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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALL-POLY PATELLA CEMENTED 38 MM DIAMETER PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ALL-POLY PATELLA CEMENTED 38 MM DIAMETER PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/12/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 an implant was opened and passed off to the sterile field. Upon opening the implant in the sterile field, the scrub tech noticed a hair on the implant. The implant was then placed back into the packaging and passed back off of the sterile field. No patient involvement.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was not confirmed, as the origin of the debris cannot be confirmed. Visual inspection of the returned product and packaging identified a hair-like debris on the device. The sterile package was already opened. Analysis of the debris confirmed it was made of biological material. The physical appearance suggests hair. Dhr was reviewed and no discrepancies were found. A definitive root cause of the reported event 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.
 
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Brand NameALL-POLY PATELLA CEMENTED 38 MM DIAMETER
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8169508
MDR Text Key130503830
Report Number0001822565-2018-06963
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 06/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2022
Device Model NumberN/A
Device Catalogue Number42540200038
Device Lot Number64029778
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/06/2019
Is This a Reprocessed and Reused Single-Use Device? No

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