MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD RIGHT SIZE 6; PROSTHESIS, KNEE

Model Number	42-5006-060-02
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
Date of Event	03/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty without complications.Subsequently, the patient has reported ongoing pain, swelling, and popping in the knee for the past four years and two months since implantation.Additionally, the patient is having range of motion issues with one knee and cannot bend or kneel.The patient has had bilateral knee replacements and it is unknown which knee is having range of motion complications.No medical intervention has been reported at the time of this report.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: all-poly patella cemented 35 mm diameter: catalog# 42540200035, lot# ni; tibia cemented 5 degree stemmed right size f: catalog# 42532007502, lot#6 3744241; articular surface fixed bearing posterior stabilized (ps) right 13 mm height: catalog# 42522400713, lot#6 2732820; palacos rg 1x40 single: catalog# 00111314001, lot# 86694600.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2022-01443; 3007963827-2022-00140; 0001822565-2022-01444; 0001822565-2022-01446.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow up report is being submitted to relay additional information.H6: proposed component (annex g) code is mechanical (g04) - femur.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified no complications during the initial surgery.No further records were provided for the ongoing reported issue.Root cause was unable to be determined.Per package insert of products, pain, poor range of motion, and swelling are known adverse effects of the system.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
No further event information at time of this report.

• Brand Name: FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD RIGHT SIZE 6
• 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: 14437665
• Report Number: 3007963827-2022-00139
• Device Sequence Number: 5151301
• Product Code: JWH
• UDI-Device Identifier: 00889024229204
• UDI-Public: (01)00889024229204(17)270731(10)63731034
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 42-5006-060-02
• Device Catalogue Number: 42500606002
• Device Lot Number: 63731034
• 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: 04/25/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male