MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BI-METRIC HIP; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Swelling (2356); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation due to unknown location.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) and complaint history review was unable to be performed as the lot/item 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.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation, warnings in package insert, material sensitivity reactions.Implantation offoreign material in tissues can result in histological reactions involving various sizes of macrophages and fibroblasts.The clinical significance of this effect is uncertain, as similar changes may occur as a precursor to or during the healing process." following review, no new risks were identified.Literature: sueyoshi, t, meding, jb, berend, me & ritter, ma (2015) short-term outcomes and taper reaction of the second generation uncemented stem in total hip arthroplasty.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.This report is being submitted late as it has been identified in remediation.Zimmer biomet complaint (b)(4).Product location unknown.

Event Description

Information was received based on review of a journal article titled, "short-term outcomes and taper reaction of the second generation uncemented stem in total hip arthroplasty".It was identified in the article that post total hip arthroplasty (tha), fifty-nine (59) bi-metric stems demonstrated distal cortical hypertrophy at follow-up of more than three-years.There has been no further information provided.

• Brand Name: UNKNOWN BI-METRIC HIP
• 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: 6964289
• MDR Text Key: 89797156
• Report Number: 0001825034-2017-09186
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2015
• Initial Date FDA Received: 10/20/2017
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other