MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HIP-M / L TAPER-STEMS-UNK; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Failure of Implant (1924); Local Reaction (2035); Metal Related Pathology (4530)

Event Date 08/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is unknown at this time if the device will be returned for analysis, due to location of device is unknown; 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: 0001822565-2021-00901.

Event Description

It was reported that the patient underwent a revision procedure due to elevated cobalt levels, significant soft tissue extension and metallosis.They have significant findings of cystic degenerative changes inclusive of around the psoas and soft tissue thickening in the capsule and pericapsular tissues.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: a4, b4, b5, g3, g6, h2, h3, h6, h10 reported event was unable to be confirmed due to limited information received from the customer.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.

• Brand Name: HIP-M / L TAPER-STEMS-UNK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11590721
• MDR Text Key: 243066646
• Report Number: 0001822565-2021-00900
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: HIP-OTHER-HEADS-UNK; HIP-OTHER-HEADS-UNK
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 73