MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X50MM ST/RST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	115400
Medical Device Problem Codes	Fracture (1260); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial surgery approximately thirteen (13) and a half months ago.The patient underwent an initial revision surgery due to a postoperative infection four (4) months ago.The glenosphere and bearing liner were revised.The patient underwent a second revision approximately two (2) months ago due to loosening of the implants.The peripheral screws and taper adapter were revised.Subsequently, the patient is being considered for a third revision surgery due to the central screw fracturing after the third surgery.The surgeon is planning to use the hhr system when the revision surgery takes place on and unknown date.
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 110027734, compr vrs glen pps min tpr adr; lot#: unknown.Item#: 180551, comp lk scr 3.5hex 4.75x20 st; lot#: 65699984.Item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 65930511.Item#: 180554, comp lk scr 3.5hex 4.75x35 st; lot#: 877630.Item#: 180555, comp lk scr 3.5hex 4.75x40 st; lot#: 849670.G2: foreign: japan.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.The root cause of the reported issue is attributed to user error as two peripheral screws were removed in the previous revision and not replaced, thereby putting excessive strain on the central screw causing it to fracture.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: COMP RVS CNTRL 6.5X50MM ST/RST
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• 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: 20351832
• Report Number: 0001825034-2024-02315
• Device Sequence Number: 8108234
• Product Code: PHX
• UDI-Device Identifier: 00880304677128
• UDI-Public: (01)00880304677128(17)320210(10)409840
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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: 115400
• Device Lot Number: 409840
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown