MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ENDO II MOD ENDO HEAD SZ 44; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369); Joint Dislocation (2374)

Event Date 05/20/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4): ep-108626, e-poly 44mm +3 mrom lnr sz26, 714400, cp152444, bi-metric fmrl c intlk 9x300 r, 980870, 139245, endo ii taper insert +6mm t1, 077430.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: 0001825034 - 2018 - 01874, 0001825034 - 2018 - 01876, 0001825034 - 2018 - 01877.

Event Description

It was reported that the patient underwent a right hip irrigation and debridement due to dislocation.A removal of hardware and griddle stone procedure were performed.A greater trochanter osteotomy non-union was also noted.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

The complaint is confirmed based on the medical reports that were provided.Review of the device history record identified no deviations or anomalies would contribute to reported event.A definitive root cause cannot be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the patient underwent a right hip irrigation and debridement due to dislocation.A removal of hardware and griddle stone procedure were performed.Continued signs of infection were also noted, continuing from a prior procedure.A greater trochanter osteotomy non-union was also noted.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: ENDO II MOD ENDO HEAD SZ 44
• 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: 7338740
• MDR Text Key: 102383037
• Report Number: 0001825034-2018-01875
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK984028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 12-139012
• Device Lot Number: 325100
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2013
• 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: 63 YR
• Patient Weight: 70