MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 9; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544)
Date of Event	08/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient had a right total knee arthroplasty.Approximately 1 year post op, the patient was prescribed 6 weeks of physical therapy due to lack of extension, difficulty ambulating, ongoing pain, and weakness.The patient completed the study, all implants remain in place, and no further intervention has been reported at this time.
Additional Manufacturer Narrative
(b)(4).This patient, per the complaint, received 6 weeks of physical therapy due to lack of extension, difficulty ambulating, and weakness.During a total knee procedure, tissues are traumatically disturbed by the inherent pulling and cutting required.This leads to inflammation related to the natural healing process, tissue fibers can also become fibrotic leading to scar tissue during healing.Symptoms experienced when this occurs typically would include decreased range of motion and limited activities of daily living.This signifies a complication post implantation that is associated with the procedure.A common treatment option for this is conservative physical therapy which would include site specific mobilization and stretching as well as special exercises to release the tightness and strengthen the muscles/tendons of the immediate joint area.This fixed state of the tissue resulting from the procedure can also produce pain at the knee.Pain is a normal anticipated finding during the postoperative recovery period as the wound, muscles and tissue heal and as the new joint implant is being used.Pain should be none to moderate, anything greater than moderate would be considered an abnormal finding and therefore would necessitate further medical intervention.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: 3007963827-2022-00217, 3007963827-2022-00218, 0002648920-2022-00181.

• Brand Name: FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 9
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15300954
• Report Number: 3007963827-2022-00216
• Device Sequence Number: 12554317
• Product Code: MBH
• UDI-Device Identifier: 00889024230408
• UDI-Public: (01)00889024230408(17)290731(10)64384981
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2022

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: 42502606602
• Device Lot Number: 64384981
• 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: 08/10/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• 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
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Race: White