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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994)
Date of Event	11/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Udi# (b)(4).Concomitant medical products: item#:cp113616; vngd ti fem cr 62.5mm rt; lot#:394780, item#:141212; biomet ilok pri tib tray 67mm; lot#: 001840, item#:189042; vngd ant stblzd brg 12x67; lot#: 748640.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00406, 0001825034-2020-00407, 0001825034-2020-00408.
Event or Problem Description
It was reported that a study patient underwent a manipulation under anesthesia, as they were experiencing pain, stiffness, and limited range of motion, approximately 1 month after their initial right total knee replacement.The patient's status was improved and was very satisfied at the 3 month check-up.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event was confirmed by review of medical records.Office visit notes identify that the patient had extreme pain when straightening the knee and when standing and twisting 1 month post op.The patient thus underwent manipulation under anesthesia.Review of the device history records did not identify any deviations or anomalies during manufacturing.A 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 31 3 PEG
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9632927
• Report Number: 0001825034-2020-00409
• Device Sequence Number: 16811333
• Product Code: JWH
• UDI-Device Identifier: 00880304431317
• UDI-Public: (01)00880304431317
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2024
• Device Model Number: N/A
• Device Catalogue Number: 184764
• Device Lot Number: 999850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 02/27/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 68