MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PAT THN 31 3 PEG; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04746, 0001825034-2019-04747, 0001825034-2019-04748, and 0001825034-2019-04749.Concomitant medical products: van ps open intl fem-lt 65, catalog#: 183128, lot#: j3867592; biomet cc cruciate tray 75mm, catalog#: 141234, lot#: j3575207; e1 vngd ps tib brg 71/75x12, catalog#: ep-183642, lot#: 895380.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient underwent left total knee arthroplasty.Subsequently, approximately twenty-three (23) months later, the patient is complaining of pain and that a cap has come loose from one of the implants.No revision procedure has been reported.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported that patient underwent left total knee arthroplasty.Subsequently, approximately twenty-three (23) months later, the patient is complaining of pain and that a cap has come loose from one of the implants.No revision procedure has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, g4, g7, h2, h3, h6, and h10.Corrected: d6 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.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: SERIES A PAT THN 31 3 PEG
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9214534
• Report Number: 0001825034-2019-04748
• Device Sequence Number: 13555699
• Product Code: JWH
• UDI-Device Identifier: 00880304436640
• UDI-Public: (01)00880304436640(17)220630(10)198680
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K040770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 184784
• Device Lot Number: 198680
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 11/22/2019; 02/04/2020
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 12/11/2019; 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 64