MAUDE Adverse Event Report: BIOMET ORTHOPEDICS E-POLY 36MM +3 HIWALL LNR SZ23; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Inadequacy of Device Shape and/or Size (1583); Metal Shedding Debris (1804); Naturally Worn (2988)

Patient Problems Scar Tissue (2060); No Information (3190)

Event Date 03/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).The device has not been returned by the patient for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Medical products: unknown ceramic head, unknown femoral stem, unknown ringloc acetabular cup.(b)(4).

Event Description

It was reported that 1 year post-implantation, the patient heard a cracking sound from the total hip joint and later a squeaking noise.The patient was subsequently revised after the acetabular liner was confirmed to have fractured.During the procedure, the ceramic head was found damaged from articulating with the acetabular shell.The head was replaced and a new liner was cemented into place instead of the usual assembly method.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

This follow up report is being filed to relay corrected and additional information.

Manufacturer Narrative

(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 10315 , 0001825034 - 2017 - 10316.

Event Description

It was reported that the patient was revised approximately one year post-implantation due to liner fracture with wear into the locking ring and cup causing deformity.It was also noted that the patient's scar tissue tinged with metal debris, and the surgeon had to downsize the cup.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: E-POLY 36MM +3 HIWALL LNR SZ23
• 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: 6654960
• MDR Text Key: 78019021
• Report Number: 0001825034-2017-04061
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK090103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: EP-108323
• Device Lot Number: 172470
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2014
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 71