MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL STEM 14 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS, EXTREMITY

Catalog Number 00434901413

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 03/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdrs were submitted for this event.Please see reports: 0001822565-2019-01239; 0001822565-2019-01240; 0001822565-2019-01241.Concomitant medical products: humeral stem 00434901413 lot 61919726; humeral liner 00434903606 lot 61882957; glenosphere 00434903611 lot 61929202; glenoid baseplate 00434903811 lot 61912949.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported the patient has pain 7 years post left reverse shoulder implantation.No further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No device was returned for review.Medical records were reviewed with no complications noted.Dhr was reviewed and no discrepancies were found.Root cause is undetermined.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 information is available at this time.

• Brand Name: HUMERAL STEM 14 MM STEM DIAMETER 130 MM STEM LENGTH
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8451050
• MDR Text Key: 139802654
• Report Number: 0001822565-2019-01238
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K130661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 00434901413
• Device Lot Number: 61919726
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/17/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 05/14/2019
• Supplement Dates FDA Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 86