MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FREEDOM STD FACE LINER SZ 26 SIZE 26; HIP PROSTHESIS

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem Not Applicable (3189)

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.The event occurred in (b)(6).

Event Description

It was reported that a constrained liner would not seat in cup.The liner would not snap into place, and was easily removed with fingers.The surgeon compared the removed liner with the constrained one by ruler.The surgeon noted that the constrained liner was smaller by circa 2mm.In this situation the surgeon opted for 27 constrained liner, in which the device fit properly.Attempts have been made, and no further information has been provided.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  reported event was unable to be confirmed due to limited information received from the customer.The reported device was returned and evaluated.Upon visual inspection the outer radius shows indentation damage.There is also circular indentation.The scallops show damage.Device history record was reviewed and no discrepancies relevant to the reported event were found.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.

• Brand Name: FREEDOM STD FACE LINER SZ 26 SIZE 26
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8030792
• MDR Text Key: 125917068
• Report Number: 0001825034-2018-10178
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• PMA/PMN Number: K030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2020
• Device Model Number: N/A
• Device Catalogue Number: 11-107325
• Device Lot Number: 121910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ITEM # UNK, RINGLOC CUP SIZE 62, LOT # UNK