MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X30 ST; PROSTHESIS, SHOULDER

Catalog Number	180553
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10: (b)(4) cat# 010000589 lot# 66061513 comp lk scr 3.5hex 4.75x30 st cat# 180553 lot# 66008658 pn 180553: visual examination of the returned products identified that both peripheral screws item 180553 are fractured.Sem analysis of the material and fracture surfaces identified fracture surface artifacts of beach marks, ratchet marks, and striations are consistent with the fatigue failure mode.Eds semi-quantitative elemental analysis found the material to be consistent with ti-6al-4v titanium alloy.Review of the device history records identified no deviations or anomalies during manufacturing.It is noted that 3 peripheral screws were placed ad the time if implantation.Per surgical technique, 4 screws are indicated for placement on implantation.However, it is unknown if this caused or contributed to the reported event.As such.A definitive root cause cannot be determined.The reported event for screw fracture has been confirmed through the returned products.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
It was reported that a patient was revised approximately 5 months post implantation due to loosening and fractured screws.The baseplate, tray, glenosphere and screws were revised.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: COMP LK SCR 3.5HEX 4.75X30 ST
• 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: 19655160
• Report Number: 0001825034-2024-01738
• Device Sequence Number: 20491148
• Product Code: KWS
• UDI-Device Identifier: 00880304677166
• UDI-Public: (01)00880304677166(17)330422(10)66008658
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2024

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: Lay User/Patient
• Device Catalogue Number: 180553
• Device Lot Number: 66008658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• 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: 06/03/2024
• Initial Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown