MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER ELEVATED RIM 36 MM I.D. SIZE NN FOR USE WITH 62 MM O.D. SIZE NN SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: liner elevated rim 36 mm i.D.Size nn for use with 62 mm o.D.Size nn shell, pn 00875201536, ln 64325979.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to hospital policy.The investigation is in process. once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient had a thr and the liner didn't sit flush during an initial surgery.Liner was removed and new liner was used as the previous one had damage around the anti-rotation tabs.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: LINER ELEVATED RIM 36 MM I.D. SIZE NN FOR USE WITH 62 MM O.D. SIZE NN SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9607488
• MDR Text Key: 189905124
• Report Number: 0001822565-2020-00207
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K093846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00875201536
• Device Lot Number: 64325979
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1