MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MAX PRI DCM TIB BRNG10X71/75MM; PEOSTHESIS, KNEE

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 05/05/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Visual examination of the provided picture found fracture of the articular surface with excessive wear.The device was not returned for further evaluation.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Insufficient information provided to perform a compatibility check.Medical records were not provided.This complaint was confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Additional associated products: unk femoral, unk tibial.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

It was reported a patient received a tka.Subsequently, the patient experienced pain resulting in a revision approximately 19 years post procedure.Poly exchange due to wear.No additional information available.

• Brand Name: MAX PRI DCM TIB BRNG10X71/75MM
• Type of Device: PEOSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14515456
• MDR Text Key: 292732372
• Report Number: 0001825034-2022-01253
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2022

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: 09/30/2008
• Device Model Number: N/A
• Device Catalogue Number: 11-146150
• Device Lot Number: 040190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2003
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male