MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS HMRL TI TRAY 44MM; PROSTHESIS, SHOULDER

Model Number	115340
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: xl-115363 085800 arcom xl 44-36 std hmrl brng.Report source foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00986.
Event or Problem Description
It was reported that during the procedure, the humeral tray and bearing were not able to be fixed and assembled together.No adverse event has been reported as a result of the malfunction.
Additional Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified a gap between both parts which indicates both parts were not fully assembled.Cosmetic inspection of the products found no damages other than wear damage to the locking ring which indicated the assembly tool had been used.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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 or Problem Description
No further event information is available at the time of this report.

• Brand Name: COMP RVS HMRL TI TRAY 44MM
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11614803
• Report Number: 0001825034-2021-00988
• Device Sequence Number: 19719473
• Product Code: KWS
• UDI-Device Identifier: 00880304475335
• UDI-Public: (01)00880304475335(17)291003(10)623140
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 115340
• Device Catalogue Number: 115340
• Device Lot Number: 623140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR