MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM - REVISION TAPER - NITRIDED CEMENTLESS 18 MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 03/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 009993017xx, unknown, 624xxxxx; 00223200207, extended 5 hole gtr w/4 cables, unknown.Report source, foreign ¿ events occurred in (b)(6).Customer has been 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 - 2017 - 08370.Requested but not returned by hospital.

Event Description

It was reported that the patient's right hip was revised approximately two years post-implantation due to stem fracture, pain, dislocation, and loosening.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Reported event was confirmed by review of x-rays and provide medical records.Radiograph review: from the radiographic review it was identified the patient's bone quality is poor and there was an evidence of the quality of proximal support was noted to be inadequate, and the size and shape of the proximal body was noted to be inadequate.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Likely root cause of the stem fracture was determined to be lack of proximal support.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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: FEMORAL STEM - REVISION TAPER - NITRIDED CEMENTLESS 18 MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7094837
• MDR Text Key: 94122298
• Report Number: 0001822565-2017-08248
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: PK992667
• 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,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 00998201823
• Device Lot Number: 60882364
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2008
• 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
• Patient Age: 64 YR
• Patient Weight: 96