MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TM SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Noise, Audible (3273)

Patient Problems Ossification (1428); Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not 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.

Event Description

It was reported the patient underwent initial left total hip arthroplasty approximately 14 years ago with a metal-on-metal construct.Subsequently upon follow up approximately 7 years later, the patient experienced a hip dislocation, instability, and clicking in the hip.Upon xray review, heterotopic ossification was noted.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 event was confirmed with x-rays and medical records received.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.

• Brand Name: UNKNOWN TM SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11648103
• MDR Text Key: 244853296
• Report Number: 0001822565-2021-00965
• Device Sequence Number: 1
• Product Code: JDI
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/12/2021
• Supplement Dates Manufacturer Received: 04/09/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN HEAD; UNKNOWN LINER; UNKNOWN STEM; UNKNOWN HEAD; UNKNOWN LINER; UNKNOWN STEM
• Patient Outcome(s): Other
• Patient Weight: 80