MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL TIBIAL CONE, MEDIUM 46X34MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	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
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.Report source: (b)(6).Additional associated products & mdrs: 42522000610 articular surface fixed brg cruciate retaining rt 10 mm lot# 64160140 mdr: 3007963827-2022-00159.42502807002 femur trabecular metal cruciate retaining std porous lot# 64025250 mdr: 0001822565-2022-01685.42532008302 tibia cemented 5 degree stemmed right size h lot# 63931209 mdr: 3007963827-2022-00160.
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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.A field action search identified no quality hold with an r-code as the reason.The complaint is confirmed.A definitive root cause cannot be determined.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.

• Brand Name: TRABECULAR METAL TIBIAL CONE, MEDIUM 46X34MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14604239
• Report Number: 3005751028-2022-00017
• Device Sequence Number: 12028217
• Product Code: JWH
• UDI-Device Identifier: 00889024308299
• UDI-Public: (01)00889024308299(17)230228(10)63909179
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102896
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

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 Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 00545001346
• Device Lot Number: 63909179
• 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: 08/26/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2018
• 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: Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 151 KG