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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 03/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: biolox delta ceramic liner # item 110003628 lot 3396322, taperloc stem # item 51-107120 lot 3442879, delta ceramic femoral head # item 650-0661 lot 2015111754, unknown screw.(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-09040, 0001825034-2018-09042.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient developed deep infection six weeks post initial surgery.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi - (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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 developed deep infection six weeks post initial surgery.Infection was resolved after i&d surgery and antibiotics treatment.

• Brand Name: G7 PPS LTD ACETABULAR SHELL
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7911120
• MDR Text Key: 121777899
• Report Number: 0001825034-2018-09038
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• 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: 010000667
• Device Lot Number: 3441507
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 41 YR
• Patient Weight: 82