MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING LEFT 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Wound Dehiscence (1154); Pain (1994); Swelling (2091); Skin Inflammation (2443); No Code Available (3191)

Event Date 06/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item # 42502606801, lot # 64193293.Item # 42532007901, lot # 64249765.Report source: foreign: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00291, 3007963827-2019-00292.Customer has indicated that the product will not be returned to zimmer biomet for investigation 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 knee arthroplasty; subsequently, the patient experienced pain, redness, warmth, swelling and discharge from the wound around the suture line approximately one month post implantation.The wound was cleaned and the patient was prescribed a seven day course of antibiotics.The adverse event has been resolved and no further medical intervention has been reported to date.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Complaint confirmed with crf report.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Crf report the patient underwent initial left tka.Crf report demonstrated that the patient experienced pain, redness, warmth, swelling and discharge from the wound around the suture line.No failure detected with the devices.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.

Event Description

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

• Brand Name: ARTICULAR SURFACE FIXED BEARING LEFT 10 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 9191315
• MDR Text Key: 162430043
• Report Number: 3007963827-2019-00293
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42511000610
• Device Lot Number: 64235954
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 95