MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK SIZE 7.5 STANDARD OFFSET; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Unintended Movement (3026)

Patient Problems Host-Tissue Reaction (1297); Local Reaction (2035); Scar Tissue (2060); Tissue Damage (2104)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801803203 versys head 60919187.00620204822 shell 61505877.00631004832 trilogy liner 61320625.00625006535 bone screw 61436685.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product 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 - 00338.

Event Description

It was reported patient underwent left hip revision approximately eight years post implantation due to elevated metal ions and altr.During the procedure, a pseudotumor was noted and excised, head and liner components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).An additional mdr report was filed for this event, please see associated report: 0001822565 - 2020 - 03300.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records identified the following: the patient had elevated metal ion levels.During the revision procedure, adverse local tissue reaction and scar tissue were identified.Black ring was observed on the trunnion.Anterior impingement at 45 degrees was noted during range of motion trials prior to dislocating the hip.The head and liner were replaced with new zimmer biomet products.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: FEMORAL STEM 12/14 NECK SIZE 7.5 STANDARD OFFSET
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10386556
• MDR Text Key: 202353877
• Report Number: 0001822565-2020-02841
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K042337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

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 Expiration Date: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 65771100700
• Device Lot Number: 61418507
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• 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): Hospitalization; Required Intervention