MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTRAMEDULLARY PLUG XL; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Muscle Weakness/Atrophy (1967); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Balance Problems (4401); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a knee surgery and approximately 3 months post-op, the patient was diagnosed with patellar tendonitis and received a steroid injection.The patient continued to have ongoing issues with pain, swelling, quadricep weakness/atrophy, balance deficits, and limited range of motion.Additional courses of physical therapy were prescribed without resolution.The patient does not want to undergo another revision and has continued to seek help for ongoing symptoms.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 183302 item name vngd ssk psc intlk fmrl 60 rt lot # 605140.183824 item name vngd sskpsc tib brg s 14x63/67 lot # 636650.185201 item name bmt 360 tib tray 63mm lot # 897880.148162 item name bmt gb knee stm 12x80 lot # 153050.00585204025 item name stem collar 25 mm lot # 64243673.00542000800 item name all poly patella size 0 8 mm thickness lot # 64212622.5036964 item name ¿ heraeus medical cement w/gent high viscocity lot # 93564861.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, g3, g6, h2, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no related deviations or anomalies during manufacturing.Medical records were provided and cover the linked complaints, the plug has been retained.A definitive root cause cannot be determined.Unable to confirm specific issues with the plug.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
There is no update to the prior event description provided.

• Brand Name: INTRAMEDULLARY PLUG XL
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19712023
• Report Number: 0001825034-2024-01818
• Device Sequence Number: 8604983
• Product Code: JDS
• UDI-Device Identifier: 00880304227354
• UDI-Public: (01)00880304227354(17)250902(10)685630
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K800144
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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: Lay User/Patient
• Device Expiration Date: 09/02/2025
• Device Model Number: N/A
• Device Catalogue Number: 130615
• Device Lot Number: 685630
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2020
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H11.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 69 KG