MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR) STANDARD POROUS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2021-00026, and 0002648920-2021-00023.Concomitant medical products: articular surface medial congruent (mc) right 10 mm height, catalog#:42522100910, lot#: 64453825.All poly patella cemented 38 mm diameter, catalog#: 42540000038, lot#: 64545012.Natural tibia trabecular metal two-peg porous fixed bearing right size h, catalog#: 42530008302, lot#: 64297605.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 the patient underwent a right knee arthroscopy for lysis of adhesions approximately three months post-implantation dud to pain, limited mobility, stiffness, and adhesions.The patient continues to report pain and stiffness.Outcome is pending.
Event or Problem Description
It was reported the patient underwent a right knee arthroscopy for lysis of adhesions approximately three months post-implantation dud to pain, limited mobility, stiffness, and adhesions.The patient continues to report pain and stiffness.The site reports the outcome has since resolved.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, b5, g3, g6, h2, h3, h6, and h10.Reported event was unable to be confirmed due to limited information received from the customer.Medical records were provided and reviewed by a health care professional via mymoblity.Review of the available records identified the following: patient experience moderate pain for almost a year after ops along with stiffness and arthrofibrosis.The patient had rom 6-105 after 3 months of post-ops.Dhr was reviewed and no discrepancies relevant to the reported event 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.

• Brand Name: FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR) STANDARD POROUS
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11285655
• Report Number: 0001822565-2021-00324
• Device Sequence Number: 14323161
• Product Code: MBH
• UDI-Device Identifier: 00889024230842
• UDI-Public: (01)00889024230842(17)300131(10)64592841
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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 Model Number: N/A
• Device Catalogue Number: 42502807002
• Device Lot Number: 64592481
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 04/15/2021
• 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: 108