MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR 40MM GLENOSPHERE +3MM COCR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 110030777

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Muscle Weakness (1967); Joint Dislocation (2374)

Event Date 03/31/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-01235, 0001822565-2022-01026.Product device code - phx.Item# 110031405; lot# 65172689, item# 110031428; lot# 64862430, item# 010000589; lot# 001910, item# 113636; lot# 64964393.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 a patient underwent a revision surgery approximately six (6) months post-implantation due to dislocation caused by disassociation of the poly bearing and tray.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10 - medical product: catalog #: 110030777, cr 40mm glenosphere +3mm cocr, lot # 65054408.H6 - proposed component code: mechanical (g04) - head.Reported event was confirmed as visual examination of the returned product identified a reverse shoulder mini humeral tray and reverse shoulder bearing were returned.As returned, damage is seen articulating surface, backside, and rim feature of the bearing.The tray exhibits damage / burnishing on the inner surface and rim features.No product was returned or pictures provided for the glenosphere; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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: CR 40MM GLENOSPHERE +3MM COCR
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 14713519
• MDR Text Key: 294922050
• Report Number: 0001822565-2022-01812
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00887868231261
• UDI-Public: (01)00887868231261(17)310723(10)65054408
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

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: 110030777
• Device Lot Number: 65054408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 06/29/2022
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male