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

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Rupture (2208)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical device: articular surface fixed bearing cruciate retaining (cr) left 11 mm height catalog # 42511000411 lot # 644971090.Multiple mdr: 0002648920-2020-00396.Customer has indicated that the product will not be returned because product location is unknown.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 during the initial procedure, the device was implanted and the surgeon felt that the posterior lip of the bearing was larger than the trial.Upon implanting the bearing prosthesis, the posterior cruciate ligament ruptured.Another device was used to complete the surgery.Attempt for further information has been made, but no further information has been provided.

• Brand Name: UNKNOWN ARTICULAR SURFACE PROVISIONAL
• Type of Device: PROSTHESIS 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: 11067325
• MDR Text Key: 223714987
• Report Number: 0001822565-2020-04210
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 12/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other