MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMET ARCOM AP PAT W/WIRE 31MM IRE 31MM; PROSTHESIS, KNEE

Catalog Number 11-150826

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Unequal Limb Length (4534); Swelling/ Edema (4577)

Event Date 05/17/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product:  vanguard cr ilok fem-lt 60 60: catalog#183024, lot#247590;  biomet ilok pri tib tray 63mm: catalog#141211, lot#480960; biomet finned pri stem 40mm: catalog#141314, lot#843360;  vngd cr tib brg 12x63/67 mm: catalog#183422, lot#839540.Multiple mdr reports have been filed for this event.Please see associated reports: 0001825034-2022-01120; 0001825034-2022-01122; 0001825034-2022-01123 and 0001825034-2022-01124.Customer has indicated that the product will not be returned to zimmer biomet for evaluation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial left total knee arthroplasty.Subsequently, the patient states to have persistent pain for the past eight years and seven months post implantation.The patient also experiences swelling in the knee with weather changes and states that the left leg has been longer than the right since the surgery.Instability was noted upon assessment and the patient underwent bone scans and lab work to determine eligibility for revision.Final outcome is pending at this time.

Manufacturer Narrative

This follow up report is being submitted to relay additional information.The following sections have been updated: b2; b3; b4; b5; d6; g3; h2; h6; h10.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial left total knee arthroplasty.Subsequently, the patient has experienced persistent pain, swelling in the knee with weather changes, and states that the left leg has been longer than the right since implantation.Instability was noted upon assessment and the patient underwent bone scans and lab work to determine eligibility for revision.Approximately nine years and nine months post implantation, the patient underwent revision surgery due to pain, swelling, and loosening.No further information has been made available at the time of this report.

Event Description

No further event information at time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records provided state that the patient was experiencing pain and instability.X-ray review by third party states that the x-rays demonstrate bilateral total knee arthroplasty without radiolucency to suggest loosening.No fracture or no significant joint effusion was seen.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.

• Brand Name: BMET ARCOM AP PAT W/WIRE 31MM IRE 31MM
• Type of Device: 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: 14287014
• MDR Text Key: 290786516
• Report Number: 0001825034-2022-01121
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 11-150826
• Device Lot Number: 453550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Sex: Female
• Patient Weight: 75 KG