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

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00999601745 femoral body - revision - nitrided - porous cementless 12/14 neck taper; standard 40 mm neck offset 63145985; 00801803601 femoral head sterile product do not resterilize 12/14 taper 63102676; item #unknown cup lot #unknown; item #unknown liner lot #.Foreign source is (b)(4).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019 -01519.

Event Description

It was reported that a patient underwent an initial hip procedure.Subsequently, approximately (4) four years post primary implantation the patient underwent a revision due to stem loosening.It was stated that under sizing of the implant in primary surgery would have contributed to the loosening.Additional information was requested, however none was available.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of of x-rays provided.Review of x-ray dated 2017, three femoral shaft cerclage wires as well as a cerclage wire affixing the greater and lesser trochanters were present.No fracture or dislocation was observed.Review of x-ray dated 16 mar 2019 identified interval development of lucency along the proximal femoral component and femoral component subsidence.There was no interval change in proximal femoral fixation hardware.Bone quality was determined to be osteopenic.Review of the device history record identified no deviations or anomalies that may have caused or contributed 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.

Event Description

There is no additional event information at the time of this report.

• Brand Name: ZMR HIP SYSTEM STEM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8562318
• MDR Text Key: 143469814
• Report Number: 0001822565-2019-01520
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K992667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/09/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00998201518
• Device Lot Number: 63083776
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 05/03/2019
• Supplement Dates FDA Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention