MAUDE Adverse Event Report: . FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT; PROSTHESIS, HIP

Catalog Number 00771100610

Device Problems Corroded (1131); Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Metal Related Pathology (4530); Insufficient Information (4580)

Event Date 02/10/2020

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 location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: part # unknown / unknown head/ lot # unknown; part #unknown / unknown cup/ lot # unknown; part #unknown / unknown liner/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2021 -00781, 0001822565 -2021 -00782, 0001822565 -2021 -00783.

Event Description

It was reported that patient underwent left hip revision procedure approximately 9 years 5 months¿ post-implantation due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported that patient underwent left hip revision procedure approximately 9 years 5 months¿ due to pain and elevated metal ions.During the revision, significant corrosion was observed between the head and neck junction with resultant psuedocapsule.The head and liner were replaced without complication.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: part # 00801803602/ femoral head/ lot # 62160602 part # 00875705201/ liner/ lot # 61912495 part # 00625006535/ bone screw/ lot # 62163465 part # 00625006525/ bone screw/ lot # 62145031 multiple mdr reports were filed for this event, please see associated reports: 0002648920 -2021 -00107.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: review of initial surgery was reviewed and no complications were noted.Review of revision surgery was reviewed and identified left hip trunnionosis.Patient presented with pain, cobalt and chromium levels were elevated.Intraoperatively the patient demonstrated corrosion of the head and neck junction of her left hip.Yet her abductors were intact.Gross abductor necrosis was not observed; however, the surrounding soft tissue demonstrated very thickened inflammatory membrane.The acetabular and femoral components were well fixed and well positioned and, as such, were retained.Pseudocapsule was obtained, showed no signs of acute inflammation.Head and liner replaced without complication.Pathology reports fibroconnective tissue and synovium with reactive fibrosis, mild chronic inflammation, and foreign body giant cell reaction, no significant increased neutrophils seen, explants for gross analysis only device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not 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.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): .; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11528999
• MDR Text Key: 241075182
• Report Number: 0001822565-2021-00779
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2021

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: 07/31/2022
• Device Catalogue Number: 00771100610
• Device Lot Number: 62114298
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 04/23/2021; 08/09/2021
• Supplement Dates FDA Received: 05/05/2021; 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 84