MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TRIAL HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

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

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Concomitant medical products: 00801802801-femoral head sterile product-64521813, 00771100710-taper stand off red neck 7 5-64144588.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02825, 0001822565 - 2020 - 02826.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.A supplier dhr for the head was not requested because a larger head was selected to resolve the laxity issue and therefore it is most likely not related to manufacturing.A definitive root cause cannot 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.

Event Description

It was reported the patient underwent an initial hip arthroplasty.During the procedure a size 7.5 ml taper stem with a -3.5mm neck length femoral head and 44mm bipolar shell and liner was opened for implantation into the patient, after a trial reduction process appeared to reveal satisfactory joint laxity and limb length.After actual implantation of implants and subsequent reduction of the implant construct, joint laxity appeared to be dissatisfactory.It was unclear whether there was any subsidence of the actual stem implant vs the trial instrument.It was also unclear whether there was any subsidence of the actual stem implant in-situ during the reduction process.A new femoral head, now a +0mm neck length, was used instead, and surgical reduction revealed joint laxity that was less dissatisfactory than the previous femoral head.This was then accepted by the surgeon.The surgical procedure was completed without any further incident.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN TRIAL HEAD
• 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: 10599663
• MDR Text Key: 209410599
• Report Number: 0001822565-2020-03368
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: NI
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• 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: 09/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1