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

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 02/06/2017

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint # (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 1822565-2017-00177, 01555, 01558.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a second revision due to dislocation.During the procedure, it was revealed that the acetabular construct had loosened and the femoral stem was retroverted.The stem retroversion was noted to have contributed to the recurrent dislocation.All components were removed and replaced.Attempts to obtain additional information have been made; however, no further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products - femoral head 28 mm diameter medium 7 mm neck length, catalog#: 00902602900, lot#:61732726.Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.It is reported that a non-zimmer biomet lima revision acetabular construct with dual mobility articulation and was used with the reported cocr head and multilock stem fullcoat.Zimmer-biomet has not confirmed the compatibility of this combination of devices, and this would be considered an off-label use of this product as indicated on the packaging insert.However, it cannot be confirmed that this incompatibility has any definitive relationship to the reported event.Root cause was unable to 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.Multiple mdr reports were filed for this event, please see associated report: 0002648920-2017-00177.

• Brand Name: UNKNOWN MULTILOCK FEMORAL 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: 6389155
• MDR Text Key: 69437534
• Report Number: 0001822565-2017-01556
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

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?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2017
• Initial Date FDA Received: 03/08/2017
• Supplement Dates Manufacturer Received: 11/29/2017
• Supplement Dates FDA Received: 11/30/2017
• 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