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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PSN FEM PS CMT CCR STD SZ 6 L PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PSN FEM PS CMT CCR STD SZ 6 L PROSTHESIS, KNEE Back to Search Results
Catalog Number 42500606001
Device Problem Naturally Worn (2988)
Patient Problems Pain (1994); Synovitis (2094)
Event Date 02/22/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-01908. Concomitant medical device: femoral component, catalog# 42500606001, lot# 63101010; tibial component, catalog# 42532007101, lot# 63021862. Reported event was unable to be confirmed due to limited information received from the customer. Device history record was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no trends were identified. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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 the patient was revised due to pain. During the revision surgery it was noticed the patient had synovial proliferation and wear on the polyethylene. No additional patient consequences were reported.
 
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Brand NamePSN FEM PS CMT CCR STD SZ 6 L
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6877377
MDR Text Key86690130
Report Number0001822565-2017-06543
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK113369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial
Report Date 09/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number42500606001
Device Lot Number63101010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/03/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/19/2017 Patient Sequence Number: 1
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