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

Model Number N/A

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

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

It was reported a journal article was retrieved from menoufia medical journal (2022) that reported a prospective study from egypt.The purpose of the study was to evaluate the early-term results of tantalum cones for reconstruction of major bone deficit in tka revision surgery.The study reviewed 10 revision knee replacement patients (7 females, 3 males).All procedures occurred at (b)(6) hospital between (b)(6) 2018 and (b)(6) 2019.¿eight cases were managed by single-stage revision (three cases were due to aseptic loosening, and five due to septic loosening but were managed by single-stage ¿2-in-1¿ technique).Two infected cases had twostage revision.¿ a cemented zimmer nexgen legacy constrained condylar knee revision system was used in conjunction with the trabecular metal cones in all cases.Cement manufacturer was not provided.The study population had a mean age of 60 years at time of surgery.Follow-up was conducted at 6 weeks, 3 months, 6 months, 1 year, 2 years and 3 years postoperatively with a mean length of follow-up for 2.85 years (range, 2.5-3 years).The study reported one patient experienced a superficial wound infection.Patient infection managed by dressing and intravenous antibiotics.

Manufacturer Narrative

(b)(4).Egypt.The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs.Unk lcck femoral cone lot# unk.Mdr: 0001822565-2023-01369.Unk femoral lot# unk.Mdr: 0001822565-2023-01424.Unk tibial lot# unk.Mdr: 0001822565-2023-01425.Journal artical reference: early results of total knee arthroplasty employing tantalum.Cones for metaphyseal bone defects.Menoufia medical journal (2022) menoufia medical journal 2022, 35:1523¿1529.

Event Description

No further event information available at the time of this report.

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.Part and lot identification are necessary for review of device history records, neither were provided.Insufficient information provided to perform a compatibility check.Complaint history review cannot be performed without product identification.Medical records were not provided.The complaint not confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: UNK ARTICULAR SURFACE
• Type of Device: 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: 17001845
• MDR Text Key: 315922256
• Report Number: 0001822565-2023-01426
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 07/27/2023
• Supplement Dates FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Prefer Not To Disclose