MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M/L TAPER SIZE 13.5 EXTENDED OFFSET; HIP PROSTHESIS

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problem Local Reaction (2035)

Event Date 06/09/2018

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 location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part#: unk, zimmer trilogy cup size 62mm, lot#: unk; part#: unk, longevity hxlpe liner size 32mm elevated 10 degree, lot#: unk.Multiple mdr reports were filed for this event, please see associated reports: head: 0001822565-2019-00517.Kwon, y., rossi, d., macauliffe, j., peng, y., arauz, p.(2018).Risk factors associated with early complications of revision surgery for head-neck taper corrosion in metal-on-polyethylene total hip arthroplasty.The journal of arthroplasty 33 (2018), 3231-3237.Https://doi.Org/10.1016/j.Arth.2018.05.046.

Event Description

It was reported that the patient was revised for symptomatic altr and elevated cocr levels.Attempts have been made and no further information has been provided.

Manufacturer Narrative

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: M/L TAPER SIZE 13.5 EXTENDED OFFSET
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8331032
• MDR Text Key: 135870832
• Report Number: 0001822565-2019-00518
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention