MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MAXIM POR ANA PRI FML 65 LT; KNEE, PROSTHESIS

Catalog Number 140072

Device Problems Material Erosion (1214); Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 07/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-06762, 0001825034-2017-07525, 0001825034-2017-07531, 0001825034-2017-07540.Concomitant medical products: biomet finned pri stem 40mm, catalog# 141314 lot# 202100 maxim por ana pri fml 65 lt, catalog # 140072, lot # 258670 biomet ilok pri tib tray 75mm, catalog # 141214, lot # 212710 biomet arcom ap pat w/wire 28mm, catalog # 11-150825, lot # 044870 max pri dcm tib brng14x71/75mm, catalog # 11-146154, lot # 353950.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to being discarded.Reported event was confirmed by review of photos.Visual inspection of the photos confirms severe wear and fracture of the tibial and the bearing components.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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 that approximately 10 years after the patient's knee procedure a revision occurred due to extreme tibial wear.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: MAXIM POR ANA PRI FML 65 LT
• Type of Device: KNEE, PROSTHESIS
• 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: 6901243
• MDR Text Key: 87651712
• Report Number: 0001825034-2017-07540
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK033489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2014
• Device Catalogue Number: 140072
• Device Lot Number: 258670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 153