MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 12MM STD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 11/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: (b)(4).Concomitant medical products: 118001, taper, lot 216550.113044, humeral head, lot 254680.Multiple mdr reports were filed for this event; please see associated reports: 0001825034-2019-01504, 0001825034-2019-01505.

Event Description

It was reported that approximately 5 months post implantation, the patient was revised due to ongoing l shoulder pain.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint was confirmed with medical records received.Initial left shoulder surgery due to glenohumeral arthritis.No complications/significant findings noted.Follow up visit noted pain, weakness, limited rom, and "popping and clicking." x-ray review noted "hemi-arthroplasty that appears proud with overstuffing." post-revision noted periprosthetic fracture sustained after a fall.No post-revision zb complications noted during follow up visits.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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: COMP PRIMARY STEM 12MM STD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8478652
• MDR Text Key: 140776130
• Report Number: 0001825034-2019-01503
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 113652
• Device Lot Number: 527180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 07/24/2019
• Supplement Dates FDA Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 52