MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER 10 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 48 MM O.D. SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Code Available (3191)

Event Date 05/31/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign county: (b)(6).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: 0001822565 - 2019 - 02874.

Event Description

It was reported that during the course of total hip arthroplasty, the liner would not lock into the shell.It was noted the shell was removed and another shell was used to finish surgery.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Upon reassessment of the reported event, it was identified that there was no issue found in the device and that it did not cause or contribute to the reported event.

Manufacturer Narrative

Upon reassessment of the reported event, it was identified that there was no issue found in the device and that it did not cause or contribute to the reported event.

• Brand Name: LINER 10 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 48 MM O.D. SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8770046
• MDR Text Key: 150830183
• Report Number: 0001822565-2019-02869
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K990135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00631004832
• Device Lot Number: 64291666
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN HEAD; UNKNOWN STEM; ZIMMER SHELL, CAT#00620204822, LOT#64005068
• Patient Weight: 75