MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL NAIL - YELLOW 9.3 MM DI 30 CM LENGTH TIBIA NAIL, STERILE

Model Number N/A

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Additional associated products & mdrs. 47248402250, 5. 0 mm dia cortical screw-red fixed angle 3. 5 mm hex head, lot# unk, mdr: 0001822565-2022-00777. 47248402250, 5. 0 mm dia cortical screw-red fixed angle 3. 5 mm hex head, lot# unk, mdr: 0001822565-2022-00778. 47248402750, 5. 0 mm dia cortical screw-red fixed angle 3. 5 mm hex head, lot# unk, mdr: 0001822565-2022-00779. 47248403050, 5. 0 mm dia cortical screw - red fixed angle 3. 5 mm hex head, lot# unk, mdr: 0001822565-2022-00780. 47248403550, 5. 0 mm dia cortical screw-red fixed angle 3. 5 mm hex head, lot#. Unk, mdr: 0001822565-2022-00781. 00114704041, 4. 0mm cann scr 1/2thr 40mm lg lot# unk, mdr: alliance partner provided devices. Zimmerbiomet does not have reporting responsibility. 00114704041 4. 0mm cann scr 1/2thr 40mm lg, lot# unk, mdr: alliance partner provided devices. Zimmerbiomet does not have reporting responsibility.

Event Description

It was reported the patient underwent a knee procedure in. Subsequently, approximately 2 years post procedure the patient has been experiencing pain with concerns of an allergic reaction. Patient also states she does not feel the bone has ever healed. Original surgery was needed due to a broken leg at which time a rod was implanted.

• Brand Name: TIBIAL NAIL - YELLOW 9.3 MM DI 30 CM LENGTH
• Type of Device: TIBIA NAIL, STERILE
• 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: 13841359
• MDR Text Key: 287558381
• Report Number: 0001822565-2022-00782
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 47249530009
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2022
• 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 Treatment Data

Date Received: 03/21/2022 Patient Sequence Number: 1