MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS MOD STEM - 12X100MM; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problems Cellulitis (1768); Erythema (1840); Fever (1858); Necrosis (1971); Pain (1994); Swelling (2091); Post Operative Wound Infection (2446)

Event Date 10/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 211225 compr srs ic seg - 60mm 875550; 110029938 compr srs 50mm dst hum bdy rt 213040; unknown nexel ulnar component ; unknown nexel articulation kit.(b)(6).The complaint is under investigation.Once the investigation has been completed, a follow-up mdr will be submitted multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 11344; 0001825034 - 2018 - 11347.

Event Description

It was reported that the patient underwent an initial right distal humeral resection and implantation of a distal humerus and elbow arthroplasty.Subsequently, the patient experienced superficial wound infection two weeks post implantation and underwent an irrigation and debridement procedure for deep wound infection six weeks post implantation.It was reported that the infection was related to procedure but not implants.No additional information was provided.

Event Description

It was reported that the patient underwent an initial right distal humeral resection and implantation of a distal humerus and elbow arthroplasty.Subsequently, the patient experienced superficial wound infection two weeks post implantation and underwent an irrigation and debridement procedure for deep wound infection, accompanied with increased pain, drainage, fever, necrotic tissue and swelling six weeks post implantation.It was reported that the infection was related to procedure but not implants.Antibiotic beads were placed; no implants were revised.No additional information was provided.

Manufacturer Narrative

The following report is being submitted to relay additional information received.The complaint was confirmed based on the medical records stating patient underwent an id procedure.Review of device history records found no deviations or anomalies.Root cause could not be determined; however, it is noted that diabetes, obesity, and cancer history all contribute to delayed wound healing and predispose the patient to infection.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: COMPR SRS MOD STEM - 12X100MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8171437
• MDR Text Key: 130609732
• Report Number: 0001825034-2018-11346
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K111746
• 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: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• 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: 211238
• Device Lot Number: 653050
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 120