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

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Hip Fracture (2349); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Event is being reported to fda on one medwatch since the limited information available indicates that a revision procedure may be necessary.Should additional information be received regarding a revision procedure, the complaint will be reassessed and, if warranted, further medwatch reports will be submitted.

Event Description

A hip revision procedure has been indicated due to stem loosening and poly; however, no revision procedure has been reported to date.It was reported the patient does not want to be revised.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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.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 contribute to monitor for trends.

Event Description

A hip revision procedure has been indicated due to stem loosening and poly wear; however, no revision procedure has been reported to date.Attempts have been made to obtain additional information; however, additional information is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for the event.Please see associated reports: 0001822565-2016-04748, 0001822565-2016-04750, 0001822565-2017-04004.

Event Description

It was reported that patient experienced possible loosening of the stem, poly wear and a hip fracture.However, no revision procedure was performed.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed through third-party review of radiographs, review of the x-ray noted "comminuted fracture of the proximal femur, fracture of the metal acetabular cup, and possible bone fracture superior lateral acetabular rim.¿ the patients bone condition was noted as generally osteopenic which may have contributed to proximal femur fracture event.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause of the event could not be determined.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 the event.Please see associated reports: 0001822565-2016-04748, 0001822565-2016-04750, 0001822565-2017-04004.

• Brand Name: UNKNOWN ZIMMER ANATOMIC STEM
• Type of Device: HIP PROSTHESIS
• 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: 6215746
• MDR Text Key: 63650625
• Report Number: 0001822565-2016-04748
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/19/2017

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 07/15/2017
• Supplement Dates FDA Received: 05/31/2017; 06/13/2017; 07/19/2017
• 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): Other