MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS LARGE FLANGE; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Tingling (2171); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 01/27/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 211254, compr srs 60mm dst hml bdy rt, 952960, 114817, disc ulna 3x115mm rt w/brng c, unknown, unknown, unknown discovery humeral condyle kit, unknown, 211236, compr srs mod stem - 8x100mm, 635430.Report source, foreign - the event occurred in the (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.The product was not returned for the investigation, therefore a visual and dimensional evaluations could not be performed.X-rays were submitted to mmi for review.Overall fit and alignment of the implants is appropriate.There is likely osteopenia present.Radiolucency is noted along the ulnar component which is suggestive of loosening.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the report event was not reported.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.This report is being submitted late as it has been identified in remediation.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04151, 0001825034 - 2018 - 04152, 0001825034 - 2018 - 04153, 0001825034 - 2018 - 04150.

Event Description

It was reported that the patient underwent right shoulder arthroplasty.During a one and three year follow up appointment, the patient experienced moderate to severe pain, difficulty sleeping, moderate tingling, difficulty opening a jar, difficulty doing heavy chores, difficulty carrying a bag, difficulty cutting, washing back, limited in social activities, and limited/ unable to do daily and recreational activities.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: COMPR SRS LARGE FLANGE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7621112
• MDR Text Key: 111734624
• Report Number: 0001825034-2018-04154
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 211270
• Device Lot Number: 916200
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2012
• 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): Other
• Patient Age: 57 YR
• Patient Weight: 54