MAUDE Adverse Event Report: BIOMET ORTHOPEDICS E1 RINGLOC ACETABULAR LINER 36MM SIZE 23; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Fracture (1260)

Patient Problems Pain (1994); Reaction (2414)

Event Date 11/10/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 9 states, "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, and/or excessive weight." number 11 states, "wear and/or deformation of articulating surfaces." number 14 states, "postoperative bone fracture and pain." this report is number 3 of 4 mdrs filed for the same patient (reference 3002806535-2016-00830 and 1825034-2016-04651 / 04653).

Event Description

Patient underwent a hip revision procedure approximately 19 months post-implantation due to pain, fractured locking ring, fractured liner, and the head wearing through the liner, creating metallosis and grey tissue/fluid that had to be removed.

Manufacturer Narrative

This follow-up report is being filed to relay additional information.Concomitant medical products - biomet taperloc femoral stem catalog#: 51-109070 lot#: 3023608.

Manufacturer Narrative

Concomitant medical products: 36mm cocr mod hd std cat: 11-363662 lot: 619500; rnglc+ ltd hole fin shl sz52 cat: 16-104152 lot: 122080; tloc 133 mp sp t1 pps ho 7x99 cat: 51-109070 lot: 3023608.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.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: E1 RINGLOC ACETABULAR LINER 36MM SIZE 23
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 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: 6094413
• MDR Text Key: 59714281
• Report Number: 0001825034-2016-04652
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: N/A
• Device Catalogue Number: EP-108223
• Device Lot Number: 882880
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2014
• 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