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

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Unstable (1667); Noise, Audible (3273)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Year of birth: (b)(6).Unknown femoral component.Unknown tibial tray.Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.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 patient underwent initial knee arthroplasty.Subsequently, the patient was revised approximately 3 years post implantation due to periprosthetic streptococcal infection.The inlay was removed and replaced.The patient later underwent a second revision approximately 5 years post first revision due to implant fracture.The inlay was removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
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.D10: 00-5968-014-51 lot 62577937 nexgen lps flex femur d, 00-5980-037-01 lot 62630914 nexgen tibia size 3, nexgen patella 32mm, unknown cement.
Event or Problem Description
It was reported the patient underwent initial left total knee arthroplasty.Subsequently, the patient was revised approximately 3 years post implantation due to pain, instability, ligament laxity, and infection.During the revision, widening of the flexion and extension gap was noted.The poly was exchanged without complication.The patient later underwent a second poly exchange approximately 5 years post second revision; during which, it was confirmed that the inlay cone was broken off.The art surface was replaced without complication.Additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified signs of use (nicked/gouged) and the post feature has fractured off.Device was submitted for further analysis.Analysis determined the post fracture in the bearing is potentially due to overloading, possibly exacerbated by impingement damage to the post from the femoral component.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: revision notes: patient presented with instability after standing long periods, difficulty extending her knee; as suspected, the inlay cone is broken off and lies in the area of the notch; new articular surface placed without complication.Root cause was unable to 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 at time of this report.

• Brand Name: ARTICULAR SURFACE
• 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: 14496042
• Report Number: 0001822565-2022-01580
• Device Sequence Number: 20338183
• Product Code: JWH
• UDI-Device Identifier: 00889024211032
• UDI-Public: (01)00889024211032(17)220331(10)63620177
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/24/2022

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: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00596203014
• Device Lot Number: 63620177
• 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: 05/13/2022
• Supplement Date Received by Manufacturer: 06/28/2022; 08/05/2022; 08/18/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 07/14/2022; 08/16/2022; 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2017
• 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.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female