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

Model Number N/A

Device Problems Mechanical Problem (1384); Unstable (1667); Noise, Audible (3273)

Patient Problems Pain (1994); Weakness (2145); Limited Mobility Of The Implanted Joint (2671)

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 14.Intraoperative or postoperative bone fracture and/or postoperative pain.Additionally, the patient is to be made aware in advance of surgery and warned of general surgical risks, possible adverse effects as listed, and to follow the instructions of the treating physician, including follow-up visits.Unique identifier (udi) #: (b)(4).This report is number 1 of 4 mdrs filed for the same event (reference 1825034-2016-04957 / 04960).

Event Description

Patient in clinical study reports pain, instability, and impingement approximately 6 weeks post implantation.Pain and instability approximately 3 months post implantation, and increased soreness, clicking, weakness and catching sensation approximately 7 months post implantation.There has been no reported revision to date.

Manufacturer Narrative

Issue is adverse event and product problem.Concomitant medical product: versa-dial/comprehensive ti standard taper, catalog#: 118001, lot#: 816430; versa-dial 54x21x64 humeral head, catalog#: 113063, lot#: 838310; lg hybrid glenoid base 4 mm, catalog#: 113956, lot#: 076130; comprehensive nano humeral pps 40 mm, catalog#: us-115740, lot#: 427500.Reported event was confirmed by review of provided x-rays.X-ray reviewer stated, "radiographic findings of anterior subluxation of the humeral head component on axillary view, predisposing to subscapularis impingement, is demonstrated.Radiographic findings of glenoid and humeral component loosening may also be associated with pain." device history record (dhr) was reviewed and no discrepancies were found.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: 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: 6137165
• MDR Text Key: 61188130
• Report Number: 0001825034-2016-04957
• Device Sequence Number: 1
• Product Code: MBF
• 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: company representative,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• 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: 376080
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2015
• 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): Other
• Patient Weight: 104