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

Model Number N/A

Device Problem Corroded (1131)

Event Date 11/29/2023

Event Type  Injury  

Event Description

It was reported the patient underwent an initial hip procedure.Subsequently, the patient was revised approximately 10 years later due to elevated ion levels.An mri showed a collection of fluid and debris.The trunnion of the stem showed signs of corrosion and discoloration.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2023-00315.D10: cat# 00630505636, lot# 62387796, liner standard 3.5 mm offset 36 mm i.D.For use with 56 mm o.D.Shell.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04) stem.The stem was not returned and remains implanted.Pictures provided show dark discoloration and bio-debris to the trunnion.No further evaluation can be made from the provided pictures.Part and lot identification are necessary for review of device history records, neither were provided for the stem.Medical records were not provided.Image assessed but not sent to mmi.Trunnion corrosion is not visible on xray and explant/intraop images within the subforms provide sufficient evidence of findings.Sending the image would not enhance the investigation.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.

• Brand Name: UNK STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18399072
• MDR Text Key: 331401606
• Report Number: 0001822565-2023-03744
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2023
• 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: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 94 KG