MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BEARING +3 MM THICKNESS 40 MM DIAMETER; SHOULDER PROSTHESIS

Catalog Number 110031428

Device Problems Detachment of Device or Device Component (2907); 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.Product device code: phx.Concomitant medical products: item# 110031405; lot# 65172689.Product has been received by zimmer biomet and 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.

Event Description

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

Manufacturer Narrative

(b)(4).D10 - medical product: catalog #: 110030777, cr 40mm glenosphere +3mm cocr, lot # 65054408.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.

• Brand Name: BEARING +3 MM THICKNESS 40 MM DIAMETER
• Type of Device: SHOULDER PROSTHESIS
• 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: 14218526
• MDR Text Key: 290164388
• Report Number: 0001822565-2022-01026
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00887868231599
• UDI-Public: (01)00887868231599(17)260221(10)64862430
• 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: 110031428
• Device Lot Number: 64862430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/27/2022
• Supplement Dates Manufacturer Received: 06/29/2022
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2021
• 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
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male