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

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 09/29/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part # 00801804002/ femoral head/ lot # 61250157; part # 00630505840 / liner standard/ lot # unknown; part # unknown / unknown trilogy cup/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00364.

Event Description

It was reported that patient underwent hip revision surgery due to pain.Patient was worked up for altr procedure cobalt level was 7.3 and mir results showed pseudotumor and a rent in the capsule.During the procedure the head was removed and showed minimal signs of corrosion, minimal discoloration on the neck of the mlt stem.The liner was removed and was damaged upon removal.The 40 liner was switched to a 36 and a biolox option head was implanted onto the mlt stem.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The provided picture of the stem show the product still implanted and covered in bio-debris.Minimal corrosion is noted.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: 1.Right total hip arthroplasty with screw fixation of the acetabular cup and possible undersized acetabular cup.Contour irregularity seen superolaterally along the acetabular cup could indicate hardware fracture.2.Question polyethylene wear of the acetabular cup.3.No evidence for metallosis.Device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown.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: UNKNOWN MLT STEM
• 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: 12682045
• MDR Text Key: 278076527
• Report Number: 0001822565-2021-03094
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 68 KG