MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HEADED SCREW 48 MM LENGTH; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
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: 0001822565-2021-03175, 3007963827-2021-00267, 3007963827-2021-00268, 3007963827-2021-00269, 0001822565-2021-03176, 0001822565-2021-03177.Concomitant medical products: femur cemented (cr) standard nitrided right size 7, item# 42572606202, lot# 64858067 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.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
Upon receipt of additional information, it was determined that this item was reported in error.The initial report was submitted in error and should be voided.This product is an instrument and was not implanted into the patient.
Event or Problem Description
Upon receipt of additional information, it was determined that this item was reported in error.The initial report was submitted in error and should be voided.This product is an instrument and was not implanted into the patient.

• Brand Name: HEADED SCREW 48 MM LENGTH
• 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: 12738527
• Report Number: 0001822565-2021-03178
• Device Sequence Number: 11765325
• Product Code: LXH
• UDI-Device Identifier: 00889024192805
• UDI-Public: (01)00889024192805(17)300726(10)64810228
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 02/25/2022

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: 00579104100
• Device Lot Number: 64810228
• 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; 02/15/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 12/08/2021; 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2020
• 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