MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE PT HYBRID GLEN POST REGENEREX; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

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

Event Date 05/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: us-115736 compr nano hmrl pps 36mm 562100; 118001 versa-dial/comp ti std taper 465390; 113032 versa-dial 42x18x46 hum head 524410; 113954 md hybrid glenoid base 4mm 692160.The complaint is under investigation.Once the investigation is completed a follow up mdr report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 09383 , 0001825034 - 2018 - 09384 , 0001825034 - 2018 - 09385.

Event Description

It was reported that the patient underwent a left shoulder arthroplasty and is experiencing stabbing pain reported in left shoulder at the three year follow-up.No additional information is available.

Manufacturer Narrative

The complaint was confirmed based on the medical records that was provided.X-rays were reviewed and there is slight anterosuperior position of the prosthetic humeral head in relation to the glenoid component.There is lucency along the superior margin of the glenoid component interface and along the glenoid stem consistent with osteolysis but no evidence of component loosening.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definite root cause cannot be determined with the information provided.F any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the patient underwent a left shoulder arthroplasty and is experiencing stabbing pain, difficulty in performing daily living activities at the three year follow-up.Medication was taken for pain control.Moderate signs of greater tuberosity tenderness were noted.It was mentioned that the event was not implant related but procedure related.No additional information is available.

• Brand Name: COMPREHENSIVE PT HYBRID GLEN POST REGENEREX
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7971546
• MDR Text Key: 123938135
• Report Number: 0001825034-2018-09386
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: PK060694
• 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: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PT-113950
• Device Lot Number: 739250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2019
• 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: 68 YR
• Patient Weight: 96