MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL LAT NC 12X140MM; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Wound Dehiscence (1154); Impaired Healing (2378)

Event Date 04/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.Year of birth: (b)(6).Concomitant medical products: item number: 163668, item name: 32 mm mod femoral head, item lot: j6138153; item number: 010000662, item name: g7 acetabular shell, item lot: 6161079; item number: 010000848, item name: g7 neutral e1 liner, item lot: 3606652.Foreign report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03857; 0001825034 - 2019 - 03858; 0001825034 - 2019 - 03859.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 experienced delayed wound healing approximately nine days post-implantation.Patient required two hip aspirations.No additional intervention was required, reports note that the wound concerns were resolved approximately one month post-implantation.No additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected 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.

Event Description

It was reported that patient experienced delayed wound healing approximately nine days post-implantation.Patient required two hip aspirations and antibiotics.No additional intervention was required, reports note that the wound concerns were resolved approximately one month post-implantation.No additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a1; a4; d4; h2; h3; h6.D4: udi# (b)(4).Reported event was confirmed with operative notes provided.Post surgery operative notes were reviewed and identified patient experienced wound discharge.Delayed wound healing.2 surgical interventions performed.Additional operative notes identified aspirated yellowish fluid mixed w/blood 1 ml.Blood results crp 6, normal wbc, slightly elevated platelets.Additional operative notes identified aspirated 5ml of normal colored synovial fluid with small amount of blood.Review of the device history records identified no related deviations or anomalies during manufacturing.A definitive root cause could not 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.

Event Description

No further event information available at the time of this report.

• Brand Name: ECHO POR FMRL LAT NC 12X140MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8946621
• MDR Text Key: 156020579
• Report Number: 0001825034-2019-03856
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K070274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• 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: 192112
• Device Lot Number: 911630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 83