MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 50D; PROSTHESIS HIP

Model Number N/A

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

Patient Problem Wound Dehiscence (1154)

Event Date 05/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: g7 neutral e1 liner # item 010000848 lot 6363084, bioloxâ® option, head # item 00877703201 lot 2784914, avenirâ® mã¼ller, stem # item 0106010104 lot 4023580.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-02529.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 medical intervention due to postop wound dehiscence approximately 23 days post initial surgery.No further information available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi#: (b)(4).Event confirmed with medical records received.Patient presented to physician¿s office with mild wound dehiscence, medical intervention noted, no indication of infection reported.Dhr was reviewed and no discrepancies relevant to the reported event were found.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.

Event Description

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

• Brand Name: G7 PPS LTD ACET SHELL 50D
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8687438
• MDR Text Key: 147610308
• Report Number: 0001825034-2019-02530
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000662
• Device Lot Number: 6339725
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 73