MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SCREWS; SCREW, FIXATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Loss of Range of Motion (2032)

Event Type  Injury  

Event Description

A retrospective study reported a 10% (2 patients) of the alps group underwent an orif for a displaced proximal humeral fracture.Subsequently, experienced avascular necrosis.No further discussion or information regarding outcome was provided.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Foreign source: switzerland.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02454.Journal article citation: dewarrat, antoine, et al."comparison of the alps and philos plating systems in proximal humeral fixation¿ a clinical retrospective study." journal of shoulder and elbow surgery, vol.31, no.3, 2022, p.147, crossmark.Crossref.Org/dialog/?doi=10.1016/j.Jse.2022.01.042&domain=pdf.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 Description

It was reported in a retrospective study that two patients underwent an open reduction and internal fixation (orif) for a displaced proximal humeral fracture approximately 18 months post implantation.Patients had developed avascular necrosis including symptoms of stiffness and reduced range of motion.There were no complications during surgery.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN SCREWS
• Type of Device: SCREW, FIXATION
• 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: 15708023
• MDR Text Key: 302770607
• Report Number: 0001825034-2022-02455
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN PLATE
• Patient Outcome(s): Other