MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X35 ST; PROSTHESIS, SHOULDER

Model Number	180554
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Unknown baseplate cat: 115396 lot: 783340 comp rvs cntrl 6.5x30mm st/rst.Cat: 180553 lot: 243940 comp lk scr 3.5hex 4.75x30 st.Cat: 180552 lot: 050600 comp lk scr 3.5hex 4.75x25 st.Cat: 180551 lot: 276310  comp lk scr 3.5hex 4.75x20 st.Cat: 180553 lot: 530830 comp lk scr 3.5hex 4.75x30 st.Unknown glenosphere.Unknown humeral stem.Cat: xl-115363 lot: 792370 arcom xl 44-36 std hmrl brng.Cat: xl-115364 lot: 875560 arcom xl 44-36 std +3 hmrl brg.Cat: 115370 lot: unknown comp rvs tray co 44mm.Foreign- united kingdom customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01091.0001825034-2023-01092.0001825034-2023 -01093.0001825034 -2023-01095.0001825034-2023-01096.0001825034-2023-01097.
Event or Problem Description
It was reported that the patient underwent a revision procedure approximately nineteen months post initial procedure due to fractured screws and loosening of baseplate.No additional patient consequences were reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, g3, g6, h1, h2, h3, h6, h10 reported event was confirmed by review of pictures.Visual examination of the provided pictures identified that the central screw and one other screw were broken.The images are not clear enough to determine if the other screws are also broken.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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 or Problem Description
No further event information is available at the time of this report.

• Brand Name: COMP LK SCR 3.5HEX 4.75X35 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: 16952937
• Report Number: 0001825034-2023-01094
• Device Sequence Number: 11629628
• Product Code: KWS
• UDI-Device Identifier: 00880304677173
• UDI-Public: (01)00880304677173(17)310226(10)227220
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 08/24/2023

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 Model Number: 180554
• Device Catalogue Number: 180554
• Device Lot Number: 227220
• Was Device Available for Evaluation?: No
• 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: 05/03/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2021
• 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 H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown