MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEU +5MM E1 LINER 40MM G; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Unspecified Infection (1930); Impaired Healing (2378)

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04352.

Event Description

It was reported a patient received a total right hip arthroplasty.Subsequently, the patient was revised approximately 3 months later due to recurrent dislocations.It is noted at a postoperative office visit the patient developed some issues with skin healing and oozing from tissues which was not coming from incision.The patient was placed on antifungal and steroid cream and within 24 hours, significant improvement in the skin was noted.During a later revision, the incision was noted to have a significant amount of devitalization of the actual incision, especially the anterior portion with a rash-like appearance, the hip incision seemed as though there might have been drainage recently.The patient states that this has not been present for 2 weeks, but was present for about 4 weeks following surgery.Devitalized skin was removed.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed with medical records provided.Review of the available records identified the following: post revision office notes stated that the patient developed some issues with skin healing and oozing from tissues which was not coming from incision.The patient was placed on antifungal and steroid cream and within 24 hours there was significant improvement in the skin.The patient had another revision procedure due to dislocation.During the procedure, the incision was noted to have a significant amount of devitalization of the actual incision, especially the anterior portion with a rash-like appearance, the hip incision seemed as though there might have been drainage recently.The devitalized skin was removed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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: G7 NEU +5MM E1 LINER 40MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9136038
• MDR Text Key: 166157578
• Report Number: 0001825034-2019-04353
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K142882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 110017226
• Device Lot Number: 6429250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 02/04/2020
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: BIOMET CUP CAT#010000667 LOT#6320942; ZIMMER HEAD CAT#00877704004 LOT#2693572; ZIMMER STEM CAT#00771101520 LOT#63989050
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 113