MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN GLENOID; SHOULDER PROSTHESIS/EXTREMITIES

Catalog Number UNKNOWN

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Erosion (1750); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).H3: 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.

Event Description

It was reported that the patient underwent an initial right shoulder arthroplasty on an unknown date.Subsequently, the patient is being considered for a revision surgery on an unknown date for an unknown reason.Multiple attempts have been made to obtain additional information with no additional information received at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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.Medical records were not provided.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.

Event Description

It was reported that the patient underwent a initial right shoulder arthroplasty on an unknown date.Subsequently, the patient is being considered for a revision surgery using a vrs glenoid due to glenoid bone erosion from loosening of component over time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.D10: medical products: item#: unknown, central screw.Item#: unknown, peripheral screw.Item#: unknown, peripheral screw.Item#: unknown, peripheral screw.Item#: unknown, peripheral screw.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: reverse total shoulder arthroplasty with significant bone erosion along the glenoid and proximal humerus with glenoid screws still partially seated within the bone.The reported event is confirmed as an x-ray was 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.Please see associated reports: 0001822565-2024-01345; 0001822565-2024-01346; 0001822565-2024-01347; 0001822565-2024-01348; 0001822565-2024-01349.

Event Description

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

• Brand Name: UNKNOWN GLENOID
• Type of Device: SHOULDER PROSTHESIS/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18699909
• MDR Text Key: 335294399
• Report Number: 0001822565-2024-00531
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/30/2024

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 03/01/2024; 03/27/2024; Not provided
• Supplement Dates FDA Received: 03/28/2024; 04/22/2024; 05/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H11 NARRATIVE.
• Patient Outcome(s): Other
• Patient Sex: Female