MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HUMERAL BEARING; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown glenosphere, unknown; unknown humeral stem, unknown; unknown baseplate, unknown; unknown humeral tray, unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03774.Customer has indicated that the product will not be returned to zimmer biomet for investigation, [remains implanted].The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent an right reverse total shoulder arthroplasty.Subsequently experienced pain, decreased activity of daily living and rom after approximately one year post primary implantation.No additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h6, h10.Reported event was confirmed by review of radiographs and medical records.Review of the available records on (b)(6)2019 identified the following: patient reports occasional pain, and some functional limitations but learned to adapt.Incision well healed arom forward flexion to 165 degrees on r.B prom in er to 60 degrees.Unable to maintain actively.X-rays taken show r side with satisfactory alignment, no evidence of periprosthetic fracture or loosening.The patient noted overall satisfaction with the outcome.Device history record (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

No further event information available at the time of this report.

• Brand Name: UNKNOWN HUMERAL BEARING
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8925487
• MDR Text Key: 155347917
• Report Number: 0001825034-2019-03775
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

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: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other
• Patient Weight: 78