MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER O.D. SHELLS; HIP PROSTHESIS

Model Number N/A

Device Problems Difficult to Remove (1528); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #00500105300 shell mm o.D.Lot #64135452.Item #unknown, unknown stem, lot #unknown.Item #unknown, unknown head, lot #unknown.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: 0001822565-2019-02587.

Event Description

It was reported that the inner ring on the bipolar shell was lodged into one side of the opening, which prevented it from locking onto the liner.The surgeon was unable to dislodge the locking ring and stated that it was not usable.When attempting to implant the shell, part of the inside locking ring scratched the liner.Another liner was used for the procedure.There was no injury or harm done to the patient due to this event.Additional information was requested however, none was available.

Event Description

Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0002648920 - 2019 - 00829.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0002648920 - 2019 - 00829.

• Brand Name: LINER O.D. SHELLS
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8712886
• MDR Text Key: 148446090
• Report Number: 0001822565-2019-02590
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K833991
• 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: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• 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: 00500105328
• Device Lot Number: 64135452
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 90 YR