MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN NEXGEN DISTAL AUGMENT 5MM; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Post Operative Wound Infection (2446); Skin Disorders (4543)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: unknown nexgen lcck femoral component size g, catalog #: ni, lot #: ni.Unknown nexgen tibial component size 5, catalog #: ni, lot #: ni.Unknown nexgen lcck articular surface 12mm, catalog #: ni, lot #: ni.Unknown nexgen femoral stem extension 18mm x 100mm, catalog #: ni, lot #: ni.Unknown nexgen tibial stem extension 14mm x 100mm, catalog #: ni, lot #: ni.Unknown nexgen distal augment 5mm, catalog #: ni, lot #: ni.Unknown nexgen posterior augment 5mm, catalog #: ni, lot #: ni.Unknown nexgen lateral augment 5mm, catalog #: ni, lot #: ni.Report source - foreign: sweden.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the devices remain implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2022-02799, 0001822565-2022-02800, 0001822565-2022-02801, 0001822565-2022-02802, 0001822565-2022-02803, 0001822565-2022-02804, 0001822565-2022-02806, 0001822565-2022-02807.

Event Description

It was reported that the patient received unknown treatment approximately one month following right knee arthroplasty to address an unknown, proximal, surgical site infection.Pre-operative notes noted the patient had psoriatic lesions over the surgical site, however, operative notes from (b)(6) 2020 noted no intra-operative complications that would have contributed to the reported event.The patient was additionally given prophylactic antibiotics preventively.No additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Superficial infections are considered a procedure related complication as no device has been reported as revised.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.During the investigation process a review of the sterile certifications were not reviewed, as no product part/lot information was provided.All devices manufactured follow acceptable sterilization processes according to published iso/aami/astm & eu guidelines.As the superficial infection was reported and no product information was provided, validation of sterile certifications cannot be performed, therefor the reported event is considered procedure related.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: UNKNOWN NEXGEN DISTAL AUGMENT 5MM
• 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: 15508843
• MDR Text Key: 300871525
• Report Number: 0001822565-2022-02805
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• 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
• Date Manufacturer Received: 11/03/2022
• 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): Required Intervention
• Patient Sex: Male