MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M/L TAPER HIP PROSTHESIS FEMORAL STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Ambulation Difficulties (2544)

Event Date 03/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00877503604 ¿ biolox delta head ¿ 2963418, 00885101136 ¿ neutral liner ¿ 64467568.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a right hip revision approximately 6 weeks post implantation due to pain, periprosthetic fracture and difficulty walking.During the surgery, the fracture was stabilized with cerclage wires and the head, liner and stem were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records noting that patient was walking and felt a sudden onset of pain with difficulty bearing weight approximately 4 weeks post op.X-rays reviewed demonstrated periprosthetic fracture with subsidence of the femoral component and no change in the position of the acetabular component.During a revision surgery, a fracture hematoma was evacuated.Prophylactic cerclage cable was placed and the stem was extracted without complication.Two additional cables were placed to secure the fracture.Dhr was reviewed and no discrepancies were found.The root cause is 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: M/L TAPER HIP PROSTHESIS FEMORAL STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9991289
• MDR Text Key: 188684603
• Report Number: 0001822565-2020-01431
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024131828
• UDI-Public: (01)00889024131828
• Combination Product (y/n): N
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00771101100
• Device Lot Number: 64430343
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2020
• 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
• Patient Weight: 83