MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS 25MM BSPLT HA+ADPTR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 010000589

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: item# 110031419; lot# 65853656 item# 115395; lot# 66365398 item# 118001; lot# 773090 item# 115310; lot# 66365250.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 that the patient underwent a revision one (1) day post-implantation due to disassociation of the taper adapter from the baseplate.The glenosphere and taper adapter remained intact when they collectively became loose from the baseplate.During the revision, the surgeon also removed and replaced the glenosphere and central screw.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 previously reported associated products was later determined to be from the revision surgery and not the initial surgery.Please see below for the associated devices implanted during the initial: item# 110031419; lot# 65808944.Item# 115310; lot# j7663362.Item# 180552; lot# 66366889.Item# 115395; lot# 66404781.Item# 180551; lot# 66300811.Item# 180550; lot# 66380461.Item# 180552; lot# 66228847.Item# 12-113558; lot# 65815352.Item# 110035368; lot# aw29af200a.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

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the glenopshere exhibited signs of being implanted including scratches and stains.The taper surface exhibited damage wear.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is not confirmed.It can be confirmed the implants were used from wear but not that they disassociated.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.

• Brand Name: COMP RVRS 25MM BSPLT HA+ADPTR
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18809427
• MDR Text Key: 336580150
• Report Number: 0001825034-2024-00551
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304532465
• UDI-Public: (01)00880304532465(17)330905(10)66075526
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193373
• 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
• Report Date: 05/22/2024

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: 010000589
• Device Lot Number: 66075526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 05/20/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female