MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SCREW; TRAUMA IMPLANT

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Metal Related Pathology (4530); Skin Inflammation/ Irritation (4545)

Event Date 12/02/2018

Event Type  Injury  

Event Description

It was reported in an anonymized study report summarizing the data of the a.L.P.S.Small and large fragment collected on a clinical study with the (b)(6) that a patient suffered from prominent metalwork and skin irritation which led to a device removal approximately 7 months post implantation.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).Medical product: catalog #: 851435507, 100deg tubular plate 7h ste, lot # unknown.Source foreign: uk, reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause could not 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00023.Requested but not returned by hospital.

• Brand Name: UNKNOWN SCREW
• Type of Device: TRAUMA IMPLANT
• 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: 16249539
• MDR Text Key: 308207373
• Report Number: 0001825034-2023-00163
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2023
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization