MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING NARROW RIGHT SIZE 7; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent initial right total knee arthroplasty.Subsequently had a manipulation under anesthesia two months post procedure due to stiffness.Components remain implanted.No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).It was reported a patient underwent manipulation under anesthesia due to stiffness approximately 2 months postop.According to tabers medical dictionary ¿ manipulation of a joint is a mobilization technique, sometimes involving a rapid thrust or stretching of a joint, with or without anesthesia.With anesthesia is (mua).Per clinical orthopaedics and related research, mua is used to treat and resolve arthrofibrosis (scar tissue) which can develop after any surgical intervention.This procedure 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.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 will not be performed.Additional associated products & mdrs: 42530006702 natural tibia trabecular metal two-peg porous bearing rt sz d lot# 64696514 mdr: 0001822565-2022-01017.42522100412 articular surface medial congruent right 12mm height lot# 64442798 mdr: 3007963827-2022-00087.00587806532 nexgen complete knee solution trabecular metal standard primary patella lot# 64296479 mdr: 3005751028-2022-00008.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 CEMENTED CRUCIATE RETAINING NARROW RIGHT SIZE 7
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14073725
• Report Number: 3007963827-2022-00086
• Device Sequence Number: 5938626
• Product Code: JWH
• UDI-Device Identifier: 00889024229921
• UDI-Public: (01)00889024229921(17)290731(10)64459627
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42502006202
• Device Lot Number: 64459627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Hispanic
• Patient Race: American Indian Or Alaskan Native