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); Arthritis (1723); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: associated products : item#: 42512100810 articular surface medial congruent (mc) left 10 mm lot#: 64473270.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: 3007963827-2021-00097.
Event or Problem Description
It was reported that the initial left total knee arthroplasty performed and subsequently, the patient underwent a manipulation under anesthesia 2 months post-op.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device; therefore, a review of the device history records was not performed.Manipulation under anesthesia is performed to increase articular motion and reduce chronic pain from arthrofibrosis.The indication for manipulation under anesthesia is related to limited range of motion and stiffness due to adhesions/scar tissue.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that due to arthrofibrosis the patient underwent a manipulation under anesthesia two months post total left knee arthroplasty.Afterward, the stiffness and limited flexion previously reported were noted to be resolved.

• 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: 11739667
• Report Number: 0001822565-2021-01183
• Device Sequence Number: 3833268
• Product Code: JWH
• UDI-Device Identifier: 00889024230798
• UDI-Public: (01)00889024230798(17)301007(10)64834476
• 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): 05/26/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42502806601
• Device Lot Number: 64834476
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/27/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 74