MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK STRAIGHT STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem Reaction (2414)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801803214 61232578 femoral head non-skirted 12/14 taper.Unknown trilogy shell.Unknown liner.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00317.0001822565 - 2020 - 02272.

Event Description

It was reported patient underwent total hip arthroplasty.Subsequently, the patient was revised approximately 10 years post implantation due to dislocation.The surgeon noticed signs of metallosis and this was evident around the base of the femoral head once explanted.The femoral stem was well fixed, but the trunion had signs of wear.Due to the stem being well fixed, fully coated, and given the surgical approach, it was decided by the surgeon to leave the stem.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Photographs of the stem, and the explanted head were evaluated and the reported event was not confirmed.Visual evaluation identified that there was dark discoloration on the surface of the head's taper and the stem's trunnion.No further evaluation could be performed with the images provided.Radiographs were provided and reviewed by a health care professional.Review of the available records identified nonspecific vague zones of periprosthetic lucencies surround the acetabular cup.No other findings related to the reported event were noted.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: UNK STRAIGHT STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10204548
• MDR Text Key: 196788630
• Report Number: 0001822565-2020-02273
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 06/28/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other