MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DIST TIB ANTLAT LT NRW 12H STE; PROSTHESIS ELBOW

Model Number N/A

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

Patient Problem Numbness (2415)

Event Date 02/13/2017

Event Type  Injury  

Event Description

It was reported that a patient had numbness over the dorsal side of the foot which resulted in a device removal.This event it was uncertain if it was related to the device, the instrumentation or the procedure.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, it was requested but not returned by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Requested but not returned by hospital.

Manufacturer Narrative

(b)(4).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: 0001825034-2022-00044, 0001825034-2022-00045, 0001825034-2022-00046, 0001825034-2022-00047, 0001825034-2022-00048, 0001825034-2022-00049, 0001825034-2022-00050, 0001825034-2022-00051, 0001825034-2022-00052, 0001825034-2022-00053, 0001825034-2022-00054, 0001825034-2022-00055.

Event Description

It was further updated that there was no other issues besides numbness.Numbness is very annoying for some individuals, so plate was removed to eliminate the possibility of plate interfering with superficial peroneal.

• Brand Name: DIST TIB ANTLAT LT NRW 12H STE
• Type of Device: PROSTHESIS ELBOW
• 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: 12920177
• MDR Text Key: 281676896
• Report Number: 0001825034-2021-03241
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 856203012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 01/07/2022
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREWS QTY 12
• Patient Outcome(s): Required Intervention; Hospitalization