MAUDE Adverse Event Report: ZIMMER BIOMET, INC. -6MM EXTENDED NEUTRAL HUMERAL TRAY; IDENTITY SHOULDER SYSTEM -6MM EXTENDED NEUTRAL HUMERAL TRAY

Catalog Number	SAHTNEM6
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 00436003600, glenosphere centric 36 mm diameter +0 mm lateral offset, lot#: 66323916.Item#: 110031419, +3mm thickness 36mm diameter bearing, lot#: 65381485.H3: 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.
Event or Problem Description
It was reported that the patient underwent an initial shoulder reverse shoulder arthroplasty approximately two (2) and a half months ago.The patient was doing great two (2) months post op having no pain and full elevation when the patient reached for a coat in a car and felt a sudden pain and clicking sensation in their shoulder.Subsequently, the surgeon scheduled the patient for a revision of the reverse identity stem.During the revision, it was discovered by the surgeon that the implant was no longer engaged.The implant was free floating in the shoulder joint.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product/provided pictures identified an identity -6mm extended neutral humeral tray.Was returned for evaluation.As returned, damage is seen in the inner tray, rim feature, and backside.The taper show wear & tear.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: single ap view of the right shoulder dated (b)(6) 2024 demonstrates narrowing of the glenohumeral joint with metal-on-metal appearance suggesting polyethylene spacer dislocation, with radiolucent spacer possibly within the subacromial sub deltoid space.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.

• Brand Name: -6MM EXTENDED NEUTRAL HUMERAL TRAY
• Common Device Name: IDENTITY SHOULDER SYSTEM -6MM EXTENDED NEUTRAL HUMERAL TRAY
• 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: 19172327
• Report Number: 0001822565-2024-01387
• Device Sequence Number: 12595320
• Product Code: MBF
• UDI-Device Identifier: 00889024627406
• UDI-Public: (01)00889024627406(17)330814(10)66046381
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K213856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: SAHTNEM6
• Device Lot Number: 66046381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Unknown