MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) 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	Muscular Rigidity (1968); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2021-00023.Concomitant medical products: articular surface fixed bearing cruciate retaining (cr) right 10 mm height, item# 42521000410, lot# 63603317.Tibia cemented 5 degree stemmed right size c, item# 42532006402, lot# 63783332.Report source - (b)(6).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 that a patient underwent a right total knee arthroplasty and, subsequently, the patient underwent a manipulation under anesthesia due to stiffness.The stiffness was noted as resolved the same day without further complication.There is no additional information at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, g3, g7, h1, h2, h3, h6, and h10.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records and radiographs were provided and reviewed by a health care professional.Radiographs were not reviewed as images would not enhance the investigation process as adhesions and scar tissue are not visible via x-ray images.Review of the available records identified the following: initial surgery: pre op rom 12-130 degrees, no patellar resurfacing, no intra op complications noted, or time 63 minutes; (approximately two months¿ post implantation) stiff knee resulting in manipulation, resolved same day; three month follow-up: moderate pain, moderate difficulties, rom 30-100 degrees, some problems with activities, health score 69 the device history records were reviewed for deviations and/or anomalies with one related anomaly/deviation identified.A definitive root cause cannot be determined.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 (CR) STANDARD RIGHT SIZE 5
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 11273119
• Report Number: 3007963827-2021-00022
• Device Sequence Number: 4607327
• Product Code: MBH
• UDI-Device Identifier: 00889024230323
• UDI-Public: (01)00889024230323(17)300228(10)64587123
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2021

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: 42502605802
• Device Lot Number: 64587123
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/15/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 65