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

Model Number N/A

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 03/12/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical product: st prc tib plt size 6 catalog # 00-5980-047-02 lot # 62678373 offset stem 11mmdx145mm catalog # 00-5988-020-11 lot # 62475615 offset stem 14mmdx145mm catalog # 00-5988-020-14 lot # 62697907 prc agmt block post sz f 5mm catalog # 00-5990-036-01 lot # 62438385 prc agmt block post sz f 5mm catalog # 00-5990-036-01 lot # 62495213 prc agmt block dist sz f 5mm catalog # 00-5990-036-10 lot # 61975294 prc agmt block dist sz f 5mm catalog # 00-5990-036-10 lot # 62485493 lcck fem implant sz f-l catalog # 00-5994-016-91 lot # 11012115.G2: new zealand.Customer has indicated that the product will not be returned because it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a revision procedure nine years post implantation due to malrotation and pain in knee attempts to obtain additional information have been made; however, no more is available at this time.

• Brand Name: NEXGEN 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: 19027817
• MDR Text Key: 339207534
• Report Number: 0001822565-2024-01116
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K173057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00596404014
• Device Lot Number: 62161442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2012
• 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; Hospitalization
• Patient Sex: Male