MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING POSTERIOR; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Unstable (1667)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Ambulation or Postural Difficulties (2544); Hyperextension (4523); Joint Laxity (4526); Joint effusion (4849)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial right knee surgery.Subsequently, the patient was revised due to instability approximately 7 years later.The articular surface was revised.The surgical technique was utilized.There was no surgical delay.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 42500606402, femur cemented posterior stabilized (ps) standard right size 8, 63066185.42532007902, tibia cemented 5 degree stemmed right size g, 63118302.42557000114, stem extension tapered cemented 14 mm diameter +30 mm length, unknown.42540000035, all poly patella cemented 35 mm diameter, unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial right knee surgery.Subsequently, the patient was revised due to instability approximately 7 years later.The articular surface was noted to be fractured and was the only component revised.The surgical technique was utilized.There was no surgical delay.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: 42557000114 - stem extension tapered cemented 14 mm diameter +30 mm length - 63171869.42540000035 - all poly patella cemented 35 mm diameter - 63049967.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product shows that the post of the bearing is missing; no post fragment was returned for evaluation.The superior surface of the bearing shows some possible light scratching and/or abrasions that appear to be typical of in-vivo use.The inferior surface shows similar light wear and/or abrasions typical of in-vivo use, plus some other marks or gouges near the centerline and locking mechanism flaring that appear to be the result of explanation damage.There is evidence of fatigue fracture.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined.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
This follow-up report is being submitted to relay additional information.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 the patient had an initial right total knee arthroplasty.Subsequently, began to have 10-15 degrees of hyperextension with significant posterior laxity and underwent a revision approximately 7 years post-op.During the revision, the surgeon found instability with a sheared off posterior stabilized polyethylene post, laxity, clear synovial effusion, and synovitis.The poly was revised for a larger size and the surgery was completed without complication.All available information has been provided.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product shows that the post of the bearing is missing; no post fragment was returned for evaluation.The superior surface of the bearing shows some possible light scratching and/or abrasions that appear to be typical of in-vivo use.The inferior surface shows similar light wear and/or abrasions typical of in-vivo use, plus some other marks or gouges near the centerline and locking mechanism flaring that appear to be the result of explanation damage.There is evidence of fatigue fracture.The device history record was reviewed and no discrepancies relevant to the reported event were found.Primary operative notes were not provided.Revision operative notes confirm that the post of the bearing has fractured.Synovitis was noted and all other components were well fixed and stable with no signs of loosening.Root cause was unable to be determined.It was reported that the patient sustained trauma prior to the revision surgery however it is not confirmed whether the trauma led to complications with the implanted prosthesis.Reported event was confirmed by returned product evaluation and provided medical records.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.

• Brand Name: ARTICULAR SURFACE FIXED BEARING POSTERIOR
• 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: 15486936
• Report Number: 0001822565-2022-02784
• Device Sequence Number: 8133603
• Product Code: MBH
• UDI-Device Identifier: 00889024243910
• UDI-Public: (01)00889024243910(17)200331(10)63004553
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/31/2025

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: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 42522400910
• Device Lot Number: 63004553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/09/2022
• Supplement Date Received by Manufacturer: 09/29/2022; 01/09/2023; 07/18/2024; 01/29/2025
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 10/06/2022; 01/09/2023; 07/30/2024; 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2015
• 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.; SEE H10.; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 127 KG