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

Device Problems Loss of or Failure to Bond (1068); Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Osteolysis (2377); Metal Related Pathology (4530)

Event Date 08/16/2018

Event Type  Injury  

Manufacturer Narrative

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 products: part # unknown / unknown shell/ lot # unknown; part #unknown / unknown head/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01534, 0001825034-2021-01535.

Event Description

It was reported a patient underwent an initial bilateral total hip arthroplasty.Subsequently, the patient underwent a right hip revision of all components 9 years post implantation due to loosening, elevated metal ions, and metallosis.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.The following sections were updated/corrected.Updated: g3; h2; h3; h6.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: revision due to loosening and metallosis, ebl 500ml.He initially had a slipped capital femoral epiphysis and then went on to have a right total hip replacement scfe not noted in initial op note.He went on to have loosening, as well as a metal debris at the site of previous metal-on metal implants.Elevated cobalt levels were noted¿aspiration did not suggest infection.Abundant fluid in the hip joint, stem was grossly loose, came out very easily by hand, osteolytic lesion in the pubis filled with cancellous bone grafting.Competitor tha placed without complication.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.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: UNKNOWN BIOMET INTEGRAL STEM
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11851716
• MDR Text Key: 251525446
• Report Number: 0001825034-2021-01536
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention