MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK GLENOID; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Bone Fracture(s) (1870); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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

It was reported patient has been indicated for revision due to unknown reason; however, no revision has been reported to date.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Insufficient information provided.Unable to perform a compatibility check.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right shoulder arthroplasty with possible underlying rotator cuff tear.Glenoid component with radiolucency suggesting loosening versus osteolysis and possible fracture of the posterior glenoid.Medical records were not provided.A definitive root cause cannot be determined.If any further information 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

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

Event Description

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

Manufacturer Narrative

Mmi review of xrays found possible underlying rotator cuff tear, and the glenoid component with radiolucency suggesting loosening of the glenoid component or osteolysis.Additionally, there is a possible fracture of the posterior glenoid bone.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.

• Brand Name: UNK GLENOID
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9677667
• MDR Text Key: 178010060
• Report Number: 0001825034-2020-00559
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN GLENOID
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 02/13/2020; 02/20/2020
• Supplement Dates FDA Received: 02/19/2020; 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other