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

Model Number	115370
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial shoulder replacement surgery, the locking ring of the humeral shell could not be opened and was not freely movable in the tray.The surgeon was unable to assemble the tray with the polyethylene bearing.A second set of implants was used to complete the procedure.There was a five minute surgical delay however no patient impact or adverse events have been reported as a result of the malfunction.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).G2: germany: foreign.Customer has indicated that the product is in the process of being returned to zimmer biomet for evaluation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product verified the part and lot number and identified the device shows slight wear and tear on the snap ring where the gap is located.The snap ring moves freely in the slot provided in the tray without issue.This complaint is not confirmed.Device history record was reviewed and no discrepancies related to the reported event were found.Investigation results concluded that the reported event was due to use error as the surgical technique states that the assembly tool should be used to assemble the tray.It was reported that an unknown clamp was used to assemble the tray instead of the bearing assembly tool.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.

• Brand Name: COMP RVS TRAY CO 44MM
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16894997
• Report Number: 0001825034-2023-01004
• Device Sequence Number: 6092224
• Product Code: PHX
• UDI-Device Identifier: 00880304543201
• UDI-Public: (01)00880304543201(17)321214(10)481810
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113069
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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: 115370
• Device Catalogue Number: 115370
• Device Lot Number: 481810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/02/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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
• Patient Sex: Prefer Not To Disclose