MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 56F; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994); Chills (2191); Post Operative Wound Infection (2446)

Event Date 11/19/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 12-115120, cer bioloxd mod hd 36mm -3 nk, 725740, 51-103130, tprlc 133 type1 pps so 13.0, 2835744, 010000858, g7 neutral e1 liner 36mm f, 3078828.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 - 01847, 0001825034 - 2018 - 01846, 0001825034 - 2018 - 01849.Product location unknown.

Event Description

It was reported that the patient underwent a revision procedure due to infection of the right hip two months post-operatively.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

The follow up report is submitted to relay additional information received.The complaint was confirmed based on the surgical op notes that was provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.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.

Event Description

It was reported that the patient underwent an irrigation and debridement (i&d) procedure approximately six (6) weeks post-implantation due to a draining surgical wound and wound infection.Then, approximately a month later, patient underwent a 1st stage revision with removal of their implants due to chronic infection of the right hip.A loose stem was found during the revision.Following right hip stage i procedure, patient underwent 2nd i&d four (4) days later.Subsequently, an additional staged procedure was performed approximately four (4) months later due to a failed stage 1 procedure with recurrent infection.Patient was revised to a spacer.Lastly, patient underwent a stage 2 re-implantation procedure three (3) months later.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: G7 PPS LTD ACET SHELL 56F
• 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: 7338739
• MDR Text Key: 102385562
• Report Number: 0001825034-2018-01848
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

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?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000665
• Device Lot Number: 2981561
• Other Device ID Number: (01)00880304524248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2013
• 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: 45 YR
• Patient Weight: 127