MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM INSERTER INSTRUMENT, HIP

Model Number N/A

Device Problems Detachment Of Device Component (1104); Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 10/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) (b)(6). Reported event was confirmed. Although the inserter was not returned, the acetabular shell was returned with a portion of the fractured inserter still seized inside of the shell's screw hole. The inserter screw fractured and a portion is bound within the threads of the shell. A hole is drilled through the screw fragment. Damage from the attempted removal can be observed on both the outside and inside of the shell. The inserter and fractured screw were not returned. 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

It is reported that the cup inserter disassociated from the acetabular cup during attempted implantation. Upon receipt of the acetabular cup, it was discovered that the inserter had seized inside the cup and fractured off inside of the cup. The fractured portion was unable to be removed. The cup was removed and replaced with another implant. No additional patient consequences were reported. Attempts have been made and no further information is available.

• Brand Name: UNKNOWN STEM INSERTER
• 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: 7434061
• MDR Text Key: 105601427
• Report Number: 0001822565-2018-02183
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/16/2018
• 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: 04/16/2018 Patient Sequence Number: 1