MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 32MM C; PROSTHESIS, HIP

Catalog Number 010000847

Device Problem Insufficient Information (3190)

Patient Problems Granuloma (1876); Impaired Healing (2378)

Event Date 05/14/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products- pps ltd acet shell, catalog # 010000661, lot # 3024724; unknown arcos modular revision stem, catalog # unknown, lot # unknown; unknown arcos modular revision cone proximal body, catalog # unknown, lot # unknown; unknown biolox delta option head, catalog # unknown, lot # unknown; unknown biolox delta option taper adapter, catalog # unknown, lot # unknown.Our investigation is ongoing.A follow-up/final report will be submitted when additional information becomes available.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-07998, 0001825034-2018-08008, 0001825034-2018-08010, 0001825034-2018-08039, 0001825034-2018-08038.Remains implanted.

Event Description

It was reported a patient presented with wound drainage from a pin-hole ulceration.The patient was treated with antibiotics and local wound treatment.The wound continued to drain and the patient underwent an irrigation and debridement with excision of granuloma.

Manufacturer Narrative

(b)(4).The follow-up report is being submitted to relay additional information.The following sections have been updated.(b)(4).Reported event was considered confirmed by review of surgical notes.No product was returned; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies were found.Review of operative notes confirm that the patient underwent irrigation and debridement of left hip wound.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: G7 NEUTRAL E1 LINER 32MM C
• 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: 7771837
• MDR Text Key: 116714561
• Report Number: 0001825034-2018-07995
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2018
• Device Catalogue Number: 010000847
• Device Lot Number: 3117789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2013
• 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: 67 YR
• Patient Weight: 136