MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RINGLOC + ACETABULAR SHELL LIMITED HOLE FINNED 56MM SIZE 24; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 09/06/2016

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 4 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." under warnings, number 6 states, "prior to seating the liner into the shell component, all surgical debris (tissue fragments, etc.) must be removed from the interior of the shell component, as debris may inhibit the locking mechanism from engaging and securing the liner into the shell component." number 8 states, "retaining ring failure and/or disassociation, which may be due to impingement, fatigue, and/or wear, increases the probability of dislocation." this report is number 2 of 3 mdrs filed for the same patient (reference 1825034-2016-03984 / 03986).

Event Description

Patient underwent a hip revision procedure approximately 3 years post-implantation due to disassociation.The acetabular cup and liner were removed and replaced.

Manufacturer Narrative

This follow-up report is being filed to relay additional information.Concomitant medical product - biomet freedom constrained femoral head catalog#: 11-107018 lot#: 021250, biomet e-poly acetabular liner catalog#: ep-108424 lot#: 389180, biomet screw catalog#: 103535 lot#: 470330, biomet screw catalog#: 103534 lot#: 863960, biomet screw catalog#: 103533 lot#: 745740.Biomet mallory head femoral stem catalog#: cp154576 lot#: 553430.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.Concomitant products: biomet freedom constrained femoral head: catalog#: 11-107018, lot#: 021250.Biomet screw: catalog#: 103535, lot#: 470330.Biomet screw: catalog#: 103534, lot#: 863960.Biomet screw: catalog#: 103533, lot#: 745740.Biomet mallory head femoral stem: catalog#: cp154576, lot#: 553430.

• Brand Name: RINGLOC + ACETABULAR SHELL LIMITED HOLE FINNED 56MM SIZE 24
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 6004126
• MDR Text Key: 56597776
• Report Number: 0001825034-2016-03985
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK093235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 16-104156
• Device Lot Number: 320590
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2016
• Initial Date FDA Received: 10/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/24/2017; 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2012
• 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