MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AB CLUSTER SHELL 58 MM; PROSTHESIS HIP

Model Number N/A

Device Problems Unstable (1667); Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 00801803205 femoral head sterile product do not resterilize 12/14 taper lot#63003010, item# unknown unknown stem lot# unknown, item# unknown unknown liner lot# unknown.Foreign source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2019 - 00340.

Event Description

It was reported that patient underwent total hip arthroplasty on an unknown date.Patient underwent revision due to instability.It was reported that liner was embedded in the shell.Attempts were made to obtain additional information; however, none was available.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following : the right hip components were anatomically aligned.No issues were noted.The reported products were reviewed for compatibility and it was determined that the following implants are not compatible: the cocr 12/14 femoral head and alumina insert.Root cause was unable to be determined.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  the following sections were  updated: a1, a2, b4, b5, g4, g7, h1, h2, h10 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.

• Brand Name: AB CLUSTER SHELL 58 MM
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8598879
• MDR Text Key: 144666662
• Report Number: 0001822565-2019-01988
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: NOT CLEARED
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 65640005822
• Device Lot Number: 61133853
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention