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

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

Event Date 03/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown, unknown head, unknown, unknown, unknown cup, unknown, unknown, unknown stem, unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.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: 0001825034 - 2018 - 01709.Remains implanted.

Event Description

It was reported that the implant popped and has been making a cruching sound since installation.The patient is also experiencing pain, swelling, and difficulty standing for a long time.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) 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 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.

• Brand Name: UNKNOWN LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7348352
• MDR Text Key: 102726845
• Report Number: 0001825034-2018-01708
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

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: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/19/2018
• Supplement Dates Manufacturer Received: 07/18/2018
• Supplement Dates FDA Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other