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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Device Packaging Compromised (2916)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/04/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the persona implant was opened in the sterile field by the nurse in the surgical room.The surgical tech noticed hair on the plastic packaging.A duplicate item was then opened.Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.From the returned product it was determined that foreign material is not found in the package and from the received photos, a hair was noticed inside the cavity.Device history record was reviewed and no discrepancies relevant to the reported event were found.Investigation results concluded that the reported event was due to manufacturing 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.
 
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Brand Name
PERSONA ARTICULAR SURFACE FIXED BEARING
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7512141
MDR Text Key108231328
Report Number0001822565-2018-02565
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
PMA/PMN Number
PK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 08/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date06/30/2022
Device Model NumberN/A
Device Catalogue Number42512400711
Device Lot Number63694432
Other Device ID Number(01) 00889024237254
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2018
Initial Date Manufacturer Received 04/17/2018
Initial Date FDA Received05/14/2018
Supplement Dates Manufacturer Received07/18/2018
Supplement Dates FDA Received08/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Age68 YR
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