MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER NEUTRAL 32 MM I.D. SIZE JJ FOR USE WITH 54 MM O.D. SIZE JJ SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - the event occurred in (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.

Event Description

It was reported that the surgeon claims that the liner was faulty, and the surgeon was unable to sit the flush on the shell despite there being no soft tissue interference.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were update/corrected updated: a continuum trilogy liner (lot 63588098) was returned for evaluation.As returned, damage is seen on the rim feature and articulating surface.Witness marks were observed on the locking features possibly trying to seat the liner in an angular position.The device was conforming to specification when it left the manufacturing facility.The device history records were reviewed and no related deviations/ anomalies were identified that affect the reported event.A definitive root cause could not 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: LINER NEUTRAL 32 MM I.D. SIZE JJ FOR USE WITH 54 MM O.D. SIZE JJ SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7396421
• MDR Text Key: 104541720
• Report Number: 0001822565-2018-01808
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: PK151448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 00875101132
• Device Lot Number: 63588098
• Other Device ID Number: (01) 00889024149151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1