MAUDE Adverse Event Report: BIOMET ORTHOPEDICS PT HYBRID GLEN POST REGENEREX; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Pain (1994); Twitching (2172); Limited Mobility Of The Implanted Joint (2671)

Event Date 11/01/2016

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 the 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 6 states, "inadequate range of motion due to improper selection or positioning of components." number 13 states, "intraoperative or postoperative bone fracture and/or postoperative pain." (b)(4).This report is number 4 of 4 mdrs filed for the same patient (reference 1825034-2017-00470 / 00471 / 00472 / 00473).

Event Description

Patient has indicated pain, instability, immobility and tenderness at the 6 week and 3 month post-operative check-ups.Patient has also reported mild pain with slight immobility along with tingling and twitching in the cervical neck radiating posteriorly into the operative shoulder with an onset of approximately 2 years post-implantation.No revision has been reported to date.

Manufacturer Narrative

This follow-up report is being filed to relay additional and corrected information, which was unknown at the time of the initial medwatch.Concomitant medical product ¿ compr nano hmrl pps 40 mm, cat#: us-115740 lot#: 115240; versa-dial/comp ti std taper, cat#: 118001 lot#: 667150; versa-dial 54x21x64 hum head, cat#: 113063 lot#: 159440; lg hybrid glenoid base 4 mm, cat#: 113956 lot#: 307250; simplex p bone cement, cat#: ni lot#: ni.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-04454, 0001825034-2017-04456, 0001825034-2017-04457, 0001825034-2017-04458, 0001825034-2017-00470, 0001825034-2017-00471, 0001825034-2017-00472, 0001825034-2017-00473.

Event Description

It was reported patient underwent a left total shoulder arthroplasty, subsequently pain, instability, and tenderness were noted at the six (6) week post-operative follow-up and continued instability was noted at the three (3) month post-operative follow-up.The issues had reportedly resolved by one (1) year post-implantation.No revision has been reported to date.

• Brand Name: PT HYBRID GLEN POST REGENEREX
• Type of Device: PROSTHESIS, SHOULDER
• 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: 6322025
• MDR Text Key: 67118559
• Report Number: 0001825034-2017-00473
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: PT-113950
• Device Lot Number: 450790
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2014
• 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): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 91