MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) LEFT SIZE 11; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Wound Dehiscence (1154)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of birth - unknown day in 1963.(b)(6) concomitant medical products: item #: 42532007101, lot #: 64355396.Item #: 42511000510, lot #: 63930822.Item #: 42540000035, lot #: 63659473.Palacos bone cement, item #: unknown, lot #: unknown.Report source: foreign (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00051, 3007963827-2020-00052, 0002648920-2020-00089.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 the patient underwent an initial left knee arthroplasty two days later the patient was seen due to a wound dehiscence and leaking from the wound.The wound was cleaned and a new patch was applied.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.It is expected that a wound heals in stages and should be of normal appearance related to the timeframe since the incision was made.A surgical wound should be well approximated without redness, warmth, swelling and/or purulent drainage for the duration of its healing.The expression wound concerns or non-healing wound would imply that the appearance of the wound deviates from what a surgical wound should appear as.It may be red, have drainage, additional pain, warmth and swelling as well as healing time may be delayed.As reported, the surgical site was draining and dehisced two days postop, requiring medical intervention.This deviation signifies an alteration in the wound healing process and our complaint categories medical: surgical site: wound complication, and medical: procedure related would be appropriate.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: FEMUR CEMENTED CRUCIATE RETAINING (CR) LEFT SIZE 11
• 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: 9728373
• MDR Text Key: 180847009
• Report Number: 3007963827-2020-00050
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• 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: 06/29/2020

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
• Device Catalogue Number: 42502607001
• Device Lot Number: 64343717
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 06/16/2020
• Supplement Dates FDA Received: 06/29/2020
• 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 Age: 56 YR
• Patient Weight: 92