MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK CUTTING EQUIPMENT; INSTRUMENT, HIP

Device Problem Unintended Movement (3026)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/18/2022

Event Type  Injury  

Event Description

It was reported that at the time of starting the preparation of the acetabulum, two problems arose altogether.The first caused by the cutting equipment, it was reported that it did not have enough torque.The second problem was with the acetabular reamers, they don't have the necessary edge.Overall, the result was that when trying to work the bone, the reamer did not move inside the acetabulum.By decreasing the pressure exerted on the cutting equipment, the instrument made an uncontrolled movement that caused a fracture in the upper part of the acetabulum.

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: (b)(6).

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not 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

No additional information on the reported event.

• Brand Name: UNK CUTTING EQUIPMENT
• Type of Device: INSTRUMENT, HIP
• 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: 13559794
• MDR Text Key: 286227276
• Report Number: 0001822565-2022-00497
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 80 KG