MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE PRIMARY STEM 12MM MINI; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 11/15/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: versa-dial 42x18x46 hum head part # 113032 lot # 384310, sm hybrid glenoid base 4mm part # 113952 lot # 168380, pt hybrid glen post regenerex part # pt-113950 lot # 404800, versa-dial/comp ti std taper part # 118001 lot # 838490, stn pn thd tip.125x2.5in 2pk part # 406669 lot # 134820.Event previously reported under 0001825034 - 2017 - 03893.Original aware date is (b)(6) 2017.Reported event of dislocation was not confirmed by review of x-rays, however x-rays do confirm radiolucency and possible loosening of glenoid and humeral stem.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 05995, 0001825034 - 2017 - 05996, 0001825034 - 2017 - 05997, 0001825034 - 2017 - 05999.

Event Description

It was reported that a patient underwent an initial shoulder arthroplasty procedure.Patient alleges constant pain, limited use of arm and inability to sleep due to shoulder dislocation when lying down.No revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: COMPREHENSIVE PRIMARY STEM 12MM MINI
• 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: 7211011
• MDR Text Key: 97943059
• Report Number: 0001825034-2017-05990
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2017

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: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 113632
• Device Lot Number: 270100
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2011
• 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 Age: 52 YR