MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR CEMENTED (CR) STANDARD NITRIDED RIGHT SIZE 7; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Unspecified Tissue Injury (4559)
Date of Event	10/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2021-00267, 3007963827-2021-00268, 3007963827-2021-00269, 0001822565-2021-03176, 0001822565-2021-03177, 0001822565-2021-03178.Concomitant medical products: articular surface (mc) right 12 mm height , item# 42522100412, lot# 64250680; articular surface (mc) right 11 mm height , item# 42522100411, lot# 64444760; tibia cemented 5 degree stemmed right size d, item# 42532006702, lot# 64765324; headed screw 48 mm length item# 00579104100, lot# 64249523; headed screw 48 mm length item# 00579104100, lot# 64810228; headed screw 48 mm length item# 00579104100, lot# 64810228.Device evaluated by mfr: 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 is experiencing pain, inflammation, and has had a high white blood cell count since she had an initial right knee arthroplasty.The patient stated that the surgeon told her that he gave her a different size because there was not an option available in her size because she is a smaller person.Patient also stated that she is allergic to nickel.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.
Event or Problem Description
It was reported that a patient reported experiencing pain and inflammation in the knee approximately one year post-implantation.A steroid injection was given in the knee due to impingement of the femoral implant on the it band due to overhang.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: right tka with no intraop complications, no patellar resurfacing/implant; eleven months post implantation- patient presents with right medial and lateral knee pain, but not overbearing; rom is 5 degree short of full extension, to 125 degree flexion; x-ray review: well positioned, well fixed tka, "femoral prosthesis is a bit wider than the femur itself", eleven and half months post implantation- patient continues to have pain laterally around the it band; steroid injection provided superficially for impingement pain device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMUR CEMENTED (CR) STANDARD NITRIDED RIGHT SIZE 7
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12738382
• Report Number: 0001822565-2021-03175
• Device Sequence Number: 4012393
• Product Code: JWH
• UDI-Device Identifier: 00889024576179
• UDI-Public: (01)00889024576179(17)300824(10)64858067
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K193223
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2022

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: 42572606202
• Device Lot Number: 64858067
• 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: 10/11/2021
• Supplement Date Received by Manufacturer: 11/30/2021; 03/08/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 12/08/2021; 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 71 KG