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 Problems Muscle Weakness (1967); Muscular Rigidity (1968); Pain (1994)

Event Date 04/28/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device product code - phx.Concomitant products: item# 00434904003; lot# 64687478.Item# 180554; lot# 658080.Item# 180553; lot# 010920.Item# 115397; lot# 100820.Item# 180554; lot# 658080.Item# 180553; lot# 657980.Item# 00434901413; lot# 64430710.Item# 405889; lot# 303210.Item# 405800; lot# 495040.Item# 110030776; lot# 65026822.Report source: foreign - event occurred in (b)(6).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 a patient was revised approximately one (1) month post-implantation due to disassociation of the glenosphere accompanied with pain, stiffness, and weakness.It was noted the size of the glenosphere and poly liner might not have been correct, causing an incorrect soft tissue balance.Attempts have been made and no further information has been provided.

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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: two views of the right shoulder demonstrate a reverse total shoulder arthroplasty and glenoid reconstruction with associated dislocation of the glenosphere.The glenosphere appears to be oversized.No fracture seen.No definite dislocation of the arthroplasty.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.A contributing factor could be the size of the glenosphere, however, that could not be confirmed as the root cause of the disassociation.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; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14310545
• MDR Text Key: 290949831
• Report Number: 0001825034-2022-01176
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304532465
• UDI-Public: (01)00880304532465(17)311201(10)295120
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K193373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

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: 295120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 05/06/2022
• Supplement Dates Manufacturer Received: 08/02/2022
• Supplement Dates FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 91 KG