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

Model Number N/A

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

Patient Problems Neuropathy (1983); Scar Tissue (2060); Cognitive Changes (2551); Metal Related Pathology (4530)

Event Date 06/29/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.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: 0002648920-2022-00167.

Event Description

It was reported that the patient underwent a revision procedure of the left hip approximately thirteen (13) years post implantation due to suspected metallosis.Trunnion of the epoch stem and the inside of the head showed signs of corrosion.The patient had a cobalt level of 19.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

H6: component code: mechanical (g04)- stem.Pictures of the stem in vivo show black debris on the trunnion, and the product is covered in bio-debris.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the description of metallosis is not confirmed radiographically.Potentially, cross-sectional imaging would better depict findings of 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.Root cause was unable to 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.

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 and/or corrected information.

Event Description

It was reported that patient had bilateral total hips.Patient underwent a left hip arthroplasty and was revised thirteen (13) years post implantation due to suspected metallosis.It was reported that the patient experienced cognitive and neuro related issue due to high metal ion levels, cobalt level of 23.3.There was noticeable scaring noted during the left revision.The head and liner were removed.The liner was destroyed upon removal and the trunnion of the 11 epoch fc and inside of the head showed visible signs of corrosion.The cocr femoral head was replaced with a biolox head and a new liner was implanted.

• Brand Name: UNKNOWN EPOCH 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: 15084407
• MDR Text Key: 296388501
• Report Number: 0001822565-2022-02185
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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,Followup
• Report Date: 05/23/2024

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 09/29/2022; 05/02/2024
• Supplement Dates FDA Received: 10/04/2022; 05/23/2024
• 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: ITEM# 00630505032, ZIMMER LINER, LOT# 61094564; ITEM# 00801803201, FEMORAL HEAD, LOT# 61123366
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 65 KG