MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL POSTERIOR STABILIZED (PS) STANDARD POROUS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Limited Mobility Of The Implanted Joint (2671)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: nexgen complete knee solution, trabecular metal standard primary patella catalog#: 00587806529 lot#: 63622755, trabecular metalâ¿¢ posterior stabilized monoblock tibial component: yellow, size 3 c-d, 10mm catalog#: 00588605310 lot#: 63700390.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 study patient underwent left total knee arthroplasty.Subsequently, at the two year clinical study visit, the patient reported severe pain, taking daily nsaids, decrease in range of motion, and dissatisfaction.No revisions or adverse events were reported.
Event or Problem Description
It was reported that a study patient underwent left total knee arthroplasty.Subsequently, at the two year clinical study visit, the patient reported severe pain, taking daily nsaids, decrease in range of motion, and dissatisfaction.No revisions or adverse events were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, b5, b7, g4, g7, h2, h6, and h10.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, g4, g7, h2, h3, h6, and h10.Reported event was unable to be confirmed due to limited information received from the customer.Crf report was provided and reviewed by a health care professional.Review of the available records identified the following: no complication was noted during the initial surgery.On (b)(6) 2018, the patient experienced pain for 2 years and administrating nsaid daily with flexion 92.Also, it was noted patient experiencing swelling, popping, stiffness.No other issue was noted.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Per package insert 87-6204-022-23 persona the personalized knee system: pain, swelling, poor range of motion are known adverse effects of the system.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 TRABECULAR METAL POSTERIOR STABILIZED (PS) STANDARD POROUS
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9985393
• Report Number: 0001822565-2020-01383
• Device Sequence Number: 14601857
• Product Code: JWH
• UDI-Device Identifier: 00889024469839
• UDI-Public: 00889024469839
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2020

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 Expiration Date: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 42500805801
• Device Lot Number: 62789560
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/29/2020
• Supplement Date Received by Manufacturer: 04/15/2020; 06/16/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 04/29/2020; 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: Required Intervention
• Patient Weight: 82