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

Device Problem Material Erosion (1214)

Patient Problems Arrhythmia (1721); Nerve Damage (1979); Pain (1994); Local Reaction (2035); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Event dates: 2015, 2017 concomitant products: item # unknown/ unknown head/ /lot # unknown.Item # unknown/ unknown cup/ /lot # unknown.Item # unknown/ unknown screw/ /lot # unknown.Item # unknown/ unknown liner/ /lot # unknown.Item # unknown/ unknown taper/ /lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2020 -01092, 0001822565 -2020 -01093, 0001822565 -2020 -01097.

Event Description

It was reported 18 years post implantation patient experienced elevated metal ions and cardiac arrhythmia.2 years after, patient experienced right lateral hip pain along with abnormal fdg pet scan consistent with chronic toxic encephalopathy and suppression mri of right hip showed areas of osteolysis at the posterior cortex and some capsular and synovial thickening consistent with adverse reaction to metallic debris.There was some loss of posterior cortex bone mineralization from tip of stem.No revision has been reported.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.Updated: b4, g4, g7, h2, h3, h6, and h10.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 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.

Event Description

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

• Brand Name: UNKNOWN STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9884679
• MDR Text Key: 185103182
• Report Number: 0001822565-2020-01090
• 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: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• 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: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other