MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL CRUCIATE RETAINING STANDARD POROUS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had tka with dr (b)(6) -standard primary with cone.Screw below implant that couldn¿t be removed so no stem used.Patient had become very unstable laterally so came for revision approximately 3 years post implantation.Once opened up we found poly had be smashed on the posterior medial corner.It was hypothesised that maybe the tibial tray was kicked into too much external rotation which caused the femur to contact more posterior and the patient may have subluxed posteromedially.There was metalossis in the joint from the femur rubbing on the tibial component as seen in the attached picture of explanted tibia.Cone was removed as we couldn¿t fix rotation.Competitor product perimeter cone used with primary baseplate and stubby stem and rotation was changed to improve contact point.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Foreign: (b)(6).Additional associated products & mdrs: 42522000610 articular surface fixed brg cruciate retaining rt 10 mm lot# 64160140.Mdr: 3007963827-2022-00159.42532008302 tibia cemented 5 degree stemmed right size h lot# 63931209.Mdr: 3007963827-2022-00160.00545001346 trabecular metal tibial cone, medium 46x34mm lot# 63909179.Mdr: 3005751028-2022-00017.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6-component code- suggested code: mechanical g4-femur.Visual examination of the provided explanted picture shows articular surface was worn and fracture at the tip.Wear can be seen medial condyle of tibial plate.No picture of the femur was provided for further evaluation.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility and it was determined that the following implants are not compatible: persona primary tibial plate and nexgen tm cone.Review of complaint history found no additional related issues for this/these item(s) and the reported part and lot combination(s).Radiographs were provided and reviewed by a health care professional.Review of the available records identified that the femur and tibial plate are interacting on the medial side resulting varus malalignment.No sign of loosening was noted.A definitive root cause cannot be determined.Per package insert: fracture and wear are known adverse effect of the system.Per package insert: states on page 03 that system components are sized by matching the femoral and tibial component sizes, styles, and orientations on the product label to the information on the articular surface component label and/or product compatibility charts included in the package insert and surgical technique manual.Mismatching may result in poor surface contact and could produce pain, decrease wear resistance, produce instability of the implant, or otherwise reduce the service life of the implant.No corrective actions, preventive actions, or field actions resulted after investigation of this event.? the complaint is confirmed.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 CRUCIATE RETAINING STANDARD POROUS
• 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: 14604218
• Report Number: 0001822565-2022-01685
• Device Sequence Number: 12028068
• Product Code: JWH
• UDI-Device Identifier: 00889024230842
• UDI-Public: (01)00889024230842(17)280721(10)64025250
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42502807002
• Device Lot Number: 64025250
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2018
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 151 KG