MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RING LOC BI-POLAR ACETABULAR CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

It is reported that the locking ring was bent on the inside of the acetabular cup.As a result, the acetabular liner did not seat as expected in the cup.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the locking ring found it to be bent and damaged.Relevant dimensional measurements of were found to be conforming.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further actions are required.Root cause was unable to 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.

• Brand Name: RING LOC BI-POLAR ACETABULAR CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6337743
• MDR Text Key: 67655475
• Report Number: 0001825034-2017-00654
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK833175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 11-165212
• Device Lot Number: 461890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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
• Patient Age: 71 YR