MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR CEMENTED STANDARD RIGHT SIZE 5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no complication was noted during the initial surgery.Office visit noted states that the patient experienced moderate pain with limited activity.The patient presented with pain, and mua was performed to remove arthrofibrosis.Mua op noted states the patient had only 0-70 degrees of rom.The tissue was very resistant tissue and very stiff for 5 weeks.It took a few minutes to get 105 degrees of rom.The mua op note dated 10 dec 2020: the patient is doing better.All prior surgery caused the patient with a lot of scar tissue.The numbness was noted, but no action was taken as it was related to post-ops symptoms.A definitive root cause cannot be determined.Per package insert: pain, limited rom are known adverse effects of the procedure.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-04153.0002648920-2020-00534.
Event or Problem Description
It was reported a patient had a right unilateral knee replacement.Approximately one month post implantation, the patient underwent manipulation under anesthesia due to stiffness and arthrofibrosis.

• Brand Name: FEMUR CEMENTED STANDARD RIGHT SIZE 5
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11029574
• Report Number: 0001822565-2020-04148
• Device Sequence Number: 13635321
• Product Code: JWH
• UDI-Device Identifier: 00889024562547
• UDI-Public: (01)00889024562547(17)300630(10)64797860
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2020

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 Model Number: N/A
• Device Catalogue Number: 42504605802
• Device Lot Number: 64797860
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/17/2020
• 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: 109