MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE HUMERAL STEM 10 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unintended System Motion (1430)

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

Event Date 01/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00434903600 poly liner plus 0 mm 62890669, 00434903611 glenosphere 36 mm diameter 62989469, 00434901500 base plate 15 mm post length uncemented 63035360.The complaint is under investigation.Once the investigation is complete a follow mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 06722, 0001822565 - 2018 - 06725, 0001822565 - 2018 - 06727.

Event Description

It was reported in a clinical study that the patient underwent initial left reverse shoulder arthroplasty and was subsequently experiencing ongoing pain, impingement at one and two year time frame follow-ups.Limited range of motion and worsening pain were noted at three year time frame follow-up.No medical intervention was required.No additional information is available at this time.

Manufacturer Narrative

The follow report is submitted to relay additional information received: corrected- updated: foreign- united kingdom the complaint is under investigation.Once the investigation is completed a follow up report will be submitted.

Event Description

No additional information is available to report at this time.

Manufacturer Narrative

The complaint was confirmed based on the clinical documents.Device history records were reviewed and no deviations and/ or anomalies were found.A definite root cause cannot be determined with the information 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 additional information is available to report at this time.

• Brand Name: TM REVERSE HUMERAL STEM 10 MM STEM DIAMETER 130 MM STEM LENGTH
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8135630
• MDR Text Key: 129433393
• Report Number: 0001822565-2018-06719
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K060704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00434901013
• Device Lot Number: 62790792
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 70