MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FREEDOM CONSTR. LINER +5 SZ 23; PROSTHESIS, HIP

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during the initial left hip procedure the constraint ring popped off the liner during impaction into the acetabular cup.The procedure was completed with another liner.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned device showed deep gouge on the scallop and inner articulating surface.The liner also showed indentations on the outer surface and on the ring groove area.The constrained ring did show small scratches which was likely from the usage and there is no other significant damage present on the ring.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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 CONSTR. LINER +5 SZ 23
• Type of Device: PROSTHESIS, HIP
• 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: 7109312
• MDR Text Key: 94965662
• Report Number: 0001825034-2017-10966
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030047
• 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,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/11/2022
• Device Model Number: N/A
• Device Catalogue Number: 11-107022
• Device Lot Number: 650650
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 07/19/2018
• Supplement Dates FDA Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2017
• 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 Age: 66 YR