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

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Noise, Audible (3273)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526)
Date of Event	11/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent initial total knee arthroplasty on unknown date.Subsequently, the patient was revised approximately 2 years post implantation due to implant fracture.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant products: 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.
Additional Manufacturer Narrative
(b)(4).Concomitant products: 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 total knee arthroplasty on unknown date.Subsequently, the patient was revised approximately 2 years post implantation due to implant fracture.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported patient underwent initial knee arthroplasty.Subsequently, the patient reported that while standing, she suddenly felt her knee joint slump backwards.Since the event, she had pain, limited mobility, and snapping in the knee.Subsequently, the patient was revised approximately one year post implantation during which, the surgeon noted that the lps peg had broken off.The poly was exchanged without complications.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A2: year of birth: 1962.
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, or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: revision op report: lps peg of the inlay is broken off and lies in the superior recess, in lay and broken pin removed, new inlay placed, full rom achieved, no complications.No signs of infection, no loosening or fracture seen on x-ray device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d1; d2; d4; d9; g4; h4.
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.Visual examination of the returned product and pictures identified signs of being implanted (wear, nicked, gouged) and the post feature has fractured off.The device was submitted for further analysis.Analysis determined the post fragment and the bearing body fit together well, as there was very little plastic deformation of the fracture surface.A small amount of damage at the anterior side of the fracture surface on the base of the post was observed, both on the left and right side edges of the post, which could possibly be due to impingement damage from the femoral component.However, there was much less damage in that area than is typical in these cases.No additional impingement damage was observed.The post fracture was caused by overloading on the post, possibly exacerbated by impingement damage 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 op report: lps peg of the inlay is broken off and lies in the superior recess, in lay and broken pin removed, new inlay placed, full range of motion achieved, no complications.No signs of infection, no loosening or fracture seen on x-ray.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.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13593998
• Report Number: 0001822565-2022-00610
• Device Sequence Number: 5236589
• Product Code: JWH
• UDI-Device Identifier: 00889024211018
• UDI-Public: (01)00889024211018(17)250228(10)64687673
• 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: 2020
• Device Explanted Year: 2021
• 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,Followup,Followup,Followup
• Report Date (Section B): 10/17/2022

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: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 00596203010
• Device Lot Number: 64687673
• 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: 02/02/2022
• Supplement Date Received by Manufacturer: 04/14/2022; 05/26/2022; 06/03/2022; 10/13/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 04/25/2022; 05/27/2022; 06/15/2022; 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female