MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM EXTENSION 6MM OFFSET SPLINED UNCEMENTED 12 MM DIAMETER +135 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	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-03473, 0001822565-2022-03474, 0001822565-2022-03475, 0001822565-2022-03476, 0001822565-2022-03477, 3007963827-2022-00325, 0001822565-2022-03479, 0001822565-2022-03481, 0001822565-2022-03483, 0001822565-2022-03484.
Event or Problem Description
It was reported a patient underwent an initial left knee arthroplasty with unknown product.The patient was revised approximately 1.5 years later due to implant loosening.At the 1 year follow up, the patient presented with left lateral knee pain that radiates to lower leg.Narcotics were prescribed.At the 2 year follow up appointment.A large left knee effusion was present.Left knee aspiration was completed in the office.No further complications reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient underwent a total knee arthroplasty.At the 1 year follow up, the patient presented with left lateral knee pain that radiates to lower leg.Narcotics were prescribed.At the 2 year follow up appointment, a large left knee effusion, tibial radiolucency, and laxity was present.Left knee aspiration was completed in the office.No further complications reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h10 h6: proposed component (annex g) code is mechanical (g04) - stem no product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified moderate pain with some effusion but no instability.X-ray found tibial radiolucency.A definitive root cause cannot be determined.Per package insert: pain, swelling are known adverse effect 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 available at the time of this report.
Additional Manufacturer Narrative
Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided as only the articular surface was revised.
Event or Problem Description
Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided as only the articular surface was revised.

• Brand Name: STEM EXTENSION 6MM OFFSET SPLINED UNCEMENTED 12 MM DIAMETER +135 MM LENGTH
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15978613
• Report Number: 0001822565-2022-03478
• Device Sequence Number: 15193666
• Product Code: JWH
• UDI-Device Identifier: 00887868250262
• UDI-Public: (01)00887868250262(17)291130(10)64602365
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/08/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42560613512
• Device Lot Number: 64602365
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 12/13/2022; 02/16/2023; 12/20/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 01/05/2023; 02/20/2023; 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Race: White