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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Osteolysis (2377); Osteopenia/ Osteoporosis (2651)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.Concomitant medical products: item # unk, hip-unknown-heads-unk, lot # unk, item # unk, hip-converge cup-cups-unk, lot # unk, item # unk, hip-unknown-liners-unk, lot # unk.Reported event was confirmed by review of radiographs.X-rays were received and reviewed.Abnormal radiolucencies seen medial and lateral to the proximal femoral bone-metal interface consistent with osteolysis.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.Multiple reports have been submitted for this event.Please see associated reports: 0001822565 - 2018 - 06506.

Event Description

It was reported that a patient was revised due to cup loosening an unknown timeframe post implantation.Attempts have been made, and no further information has been provided.

• Brand Name: UNKNOWN ZIMMER NATURAL STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8232906
• MDR Text Key: 132576530
• Report Number: 0001822565-2019-00142
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other