MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PAT STD 34 3 PEG; PROSTHESIS KNEE

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Event Description

It was reported patient is experiencing pain, instability and popping in knee approximately 3 years post implantation.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

(b)(4).Concomitant medical products: e1 vngd as tib brg 13x71, catalog #: ep-189063, lot #: 315520.Vanguard cr ilok fem-rt 62.5, catalog #: 183006, lot #: j6462776.Biomet cc i-beam tray 71mm, catalog #: 141223, lot #: j6453610.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2022-01661, 0001825034-2022-01669, 0001825034-2022-01673.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10 reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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.

• Brand Name: SERIES A PAT STD 34 3 PEG
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15074380
• MDR Text Key: 296301210
• Report Number: 0001825034-2022-01675
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 00880304434349
• UDI-Public: (01)00880304434349(17)240222(10)641100
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

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 Date: 02/22/2024
• Device Model Number: N/A
• Device Catalogue Number: 184766
• Device Lot Number: 641100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 09/16/2022
• Supplement Dates FDA Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 77 KG