MAUDE Adverse Event Report: ZIMMER, INC. ZMR HIP SYSTEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 11/30/2016

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 Description

Patient's hip was revised approximately two years post-implantation due to fractured stem.No additional information provided.

Manufacturer Narrative

This follow up report is being filed to relay corrected and additional information.Concomitant medical products - unknown zmr cone body, unknown femoral head, unknown acetabular component.Reported event was confirmed through photos.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action is required as no trends were identified.Root cause was unable to 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.

• Brand Name: ZMR HIP SYSTEM
• 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: 6216089
• MDR Text Key: 63661964
• Report Number: 0001822565-2016-04862
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK992667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2016

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 Expiration Date: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00998202218
• Device Lot Number: 62042053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: 09/15/2017
• Supplement Dates FDA Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2012
• 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