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

Device Problem Material Erosion (1214)

Patient Problems Encephalopathy (1833); Fall (1848); Fatigue (1849); Bone Fracture(s) (1870); Hearing Impairment (1881); Memory Loss/Impairment (1958); Pain (1994); Visual Impairment (2138); Depression (2361); Sleep Dysfunction (2517); Cognitive Changes (2551)

Event Date 03/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as product remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted concomitant medical products: item # unknown/unknown head/ lot # unknown, item # unknown/ unknown cup/ /lot # unknown, item # unknown/unknown stem/ lot # unknown, item # unknown/unknown liner/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2020 -01227, 0001822565 -2020 -01228.

Event Description

It was reported that 6 years post left hip implantation patient began experiencing pain and elevated metal ions.Patient reported progressive memory and cognitive problems, worsening of depressive mood disorder, pain tolerance dulling, sleep disorder, fatigue, hearing and vision worsening.No revision has been reported at this time.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.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) reviewed was unable to be performed as the lot number of the device involved in the event is unknown.Root cause is 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.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN NECK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9921327
• MDR Text Key: 186725049
• Report Number: 0001822565-2020-01235
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• 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: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• 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
• Date Manufacturer Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other