MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X40 ST; PROSTHESIS, EXTREMITIES

Catalog Number	180555
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02196.Device product code - phx.Product id for five screws was provided; however, it is unknown which two screws of the five fractured.Below are the other possible screws: item# 180555; lot# 409630.Item# 180554; lot# 851040.Item# 180553; lot#unk.Item# 115398; lot#704800.Concomitant products: item# 180555; lot# 409630.Item# 180554; lot# 851040.Item# 180553; lot# unk.Item# 115398; lot# 704800.Item# pm0002521; lot# 762790.Item# xl-115363; lot# 593390.Item# 115370; lot# 858970.Item# 115310; lot# 618920.Report source: foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.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.
Event or Problem Description
It was reported patient underwent a revision surgery approximately two (2) years post-implantation due to two of the screws fracturing.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/corrected: b4; b5; g3; g6; h1; h2; h3; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no readily detected on image 2 is an embedded fractured off distal screw component within the scapula, appearing adjacent and medial to the distal tip of the inferior most screw.The inferior most screw tip is intact, but the donor site of the fracture tip is likely of the 2nd most inferior screw.Additionally noted is a fracture of the 2nd most proximal screw, also embedded in the scapula.Similar findings are also seen on image 1, but not as readily characterized.Remainder of hardware is unremarkable.No periprosthetic lucencies.No dislocation.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information 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 available at the time of this report.

• Brand Name: COMP LK SCR 3.5HEX 4.75X40 ST
• Common Device Name: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12267190
• Report Number: 0001825034-2021-02195
• Device Sequence Number: 4101172
• Product Code: PHX
• UDI-Device Identifier: 00880304677180
• UDI-Public: (01)00880304677180(17)270512(10)409630
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K130390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 11/22/2021

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: 180555
• Device Lot Number: 409630
• 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: 07/12/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose