MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN REGENEREX RINGLOC+ SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 05/31/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is based on the initial information and the information from investigation.Concomitant medical products: unknown liner catalog#: ni lot#: ni, unknown head catalog#: ni lot#: ni, unknown stem catalog#: ni lot#: ni.Literature- sueyoshi, t., keating, e.M., ritter, m.A., meding, j.B., & brunsman, m.J.(2016).Early clinical outcomes with a 3-d porous titanium acetabular cup.Open journal of orthopedics, 06(06), 121-125.Doi:10.4236/ojo.2016.66018.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-06018-1, 0001825034-2017-06324, 0001825034-2017-06325.Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.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.

Event Description

It was reported that the patient was revised 11 month post primary total hip arthroplasty, due to liner fracture.The patient was diagnosed by a secondary osteoarthritis after traumatic hip injury.During the surgery, the implanted cup was found stable and firm but the inner locking was damaged.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: UNKNOWN REGENEREX RINGLOC+ SHELL
• 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: 6792813
• MDR Text Key: 82657278
• Report Number: 0001825034-2017-06323
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 41 YR