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

Model Number N/A

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

Patient Problem Wound Dehiscence (1154)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# unot 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: unknown unknown liner lot# unknown, item# unknown unknown shell lot# unknown, item# unknown unknown head lot# unknown.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.

Event Description

It was reported that patient underwent total hip arthroplasty approximately 1 year ago.5 weeks post op, patient presented five weeks post-op with slow wound healing and some granulation tissue over the area.Subsequently, patient underwent wound revision and hip aspiration under fluoro which revealed rare polys, no epis, or organisms seen.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed from medical records received.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Revision operative notes states patient had a small area mid incision that had delayed healing.Root cause could not be determined with information available.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: UNKNOWN STEM
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7770325
• MDR Text Key: 116700282
• Report Number: 0001825034-2018-08005
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 159