MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STANDARD OFFSET12.5 REDUCED NECK 12/14 NECK TAPER FEMORAL STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Failure of Implant (1924); Pain (1994); Synovitis (2094); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 02/22/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: cat# 01.00181.540 lot # 2314687 metasul large diameter hd 54/t cat# 01.00185.146 lot# 2326742 head adapter m/0 12/14-18/20 cat# 01.00214.160 lot# 2316371 durom us acet cmpnt 60/54 t 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

It was reported that the patient underwent an initial right metal-on-metal total hip arthroplasty.Subsequently, the patient was revised approximately 16 years later due to pain and elevated cobalt and chromium levels.During the revision, synovitis and trunnion corrosion were noted.The well-fixed stem and acetabular shell were left in place, and a dual mobility construct was placed.There were no complications noted during the revision procedure.Upon follow up one year later, the patient¿s metal ion levels were within normal limits.Attempts have been made and no further information has been provided.

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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right mom tha was performed.The patient was revised approximately 16 years later due to pain and elevated metal ions.During the revision, trochanteric bursitis was noted, as well as black debris noted to the trunnion.The head was explanted for a dm bearing construct, no complications noted.After the revision, the metal ion levels returned to normal.Root cause unchanged.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: STANDARD OFFSET12.5 REDUCED NECK 12/14 NECK TAPER FEMORAL 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: 16991230
• MDR Text Key: 315825296
• Report Number: 0001822565-2023-01405
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 00771101210
• Device Lot Number: 60414073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2006
• 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: Male