MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI HUMERAL TRAY STANDARD THICKNESS +0 MM TAPER OFFSET 40 MM DIAMETER; SHOULDER, PROSTHESIS

Catalog Number 110031399

Device Problems Detachment of Device or Device Component (2907); Noise, Audible (3273)

Patient Problems Fall (1848); Failure of Implant (1924)

Event Date 01/31/2022

Event Type  Injury  

Event Description

It was reported the patient underwent a shoulder procedure.Subsequently, the patient was revised due to noise on (b)(6) 2022.During revision, the poly was seen to be disassociated.

Manufacturer Narrative

(b)(4).Foreign: (b)(6).Bearing +3 mm thickness 40 mm diameter cat:110031428 lot: 64833634.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).Foreign: (b)(6).Bearing +3 mm thickness 40 mm diameter cat:110031428 lot: 64833634.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported the patient underwent a shoulder procedure.Subsequently, the patient was revised due to noise on (b)(6) 2022.During revision, the poly was seen to be disassociated.

Manufacturer Narrative

Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: reverse-type glenohumeral arthroplasty has been performed and the implants are anatomically aligned.However, there is apparent metal-on-metal contact of the glenosphere and humeral implant with superior displacement of the polyethylene spacer.No fracture is identified.Bone quality is mildly osteopenic.Visual examination of the provided pictures identified the item and lot numbers for the tray are verified.The tray and bearing are not attached and biological debris is present on both parts in the provided picture.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.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 is 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.The following sections were updated: b4, b5, d10, g3, g7, h1, h2, h10 visual examination of the returned product identified a reverse shoulder mini humeral tray (lot 65118459) and a reverse shoulder poly bearing were returned.As returned, the humeral tray shows damage in the form of burnishing on the rim near the etch detail.The poly bearing shows damage throughout the backside features and on the rim above the spherical diameter.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: MINI HUMERAL TRAY STANDARD THICKNESS +0 MM TAPER OFFSET 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: 13633327
• MDR Text Key: 286327116
• Report Number: 0001822565-2022-00639
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00887866231315
• UDI-Public: (01)00887866231315(17)310515(10)65118459
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K181611
• 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,Followup
• Report Date: 05/09/2022

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: 110031399
• Device Lot Number: 65118459
• 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: 01/31/2022
• Initial Date FDA Received: 03/01/2022
• Supplement Dates Manufacturer Received: 03/28/2022; 05/09/2022
• Supplement Dates FDA Received: 03/31/2022; 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• 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 H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male