MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN STEM; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 04/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).It is unknown if the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Concomitant products - unknown head, unknown cup and unknown liner.

Event Description

It was reported that the patient was revised due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported that the patient was revised due to instability.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Additional: updated (b)(4) modular neck 12/14 neck taper use with +0 heads only (b)(4).Complaint was confirmed with return of the compatible component.The neck was returned and evaluated.The modular neck shows damage between the conical taper and elliptical taper, indicating impingement.The elliptical taper exhibits fretting/wear.Damage is too severe for dimensional analysis.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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.

• Brand Name: UNKNOWN STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6609513
• MDR Text Key: 76590975
• Report Number: 0001822565-2017-03796
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention