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

Model Number N/A

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

Patient Problem Unspecified Infection (1930)

Event Date 04/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: biomet g7 shell cat#010000662 lot#6395394, biomet stem cat#192808 lot# 668350, biomet taper sleeve cat#650-1064 lot#2955104, biomet head cat#650-1057 lot#2955098, zimmer bone screw cat#00625006530 lot#64228001, biomet liner cat#010000817 lot#6354149.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 02327, 0001825034 - 2019 - 02329.

Event Description

It was reported the patient underwent primary left tha.Subsequently, the patient was admitted to the hospital approximately 2 months post implantation due to infection where patient underwent a two-stage revision secondary to the presence of (b)(6).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.Reported event was confirmed with operative notes provided.Operative notes demonstrated that the patient had i & d surgery before deep infection was identified, and it was determined that not only the head and liner, but also the cup and stem needed revised.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot 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.

• Brand Name: UNKNOWN LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8645322
• MDR Text Key: 146209006
• Report Number: 0001825034-2019-02328
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 31-323240
• Device Lot Number: 949630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2019
• 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
• Patient Weight: 88