MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 62H; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Source: (b)(6).Concomitant medical devices: catalog number: 103533 lot number:2018072302 brand name: ti low profile screwcatalog; number: 103534 lot number:2017070505 brand name: ti low profile screw; catalog number:103533 lot number:2018050588 brand name: ti low profile screw; catalog number:650-0888 lot number: 6651345 brand name: 36mm 12/14 tpr fem hd std]; catalog number:010000782 lot number:3645897 brand name: g7 liner.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03585.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.Device not returned for evaluation.

Event Description

It was reported that the patient was revised due to disassociation of the liner from the shell approximately 4 days post implantation.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.  reported event was unable to be confirmed due to limited information received from the customer.Review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.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

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

• Brand Name: G7 PPS LTD ACET SHELL 62H
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10587211
• MDR Text Key: 208574239
• Report Number: 0001825034-2020-03628
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000668
• Device Lot Number: 6691972
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention