MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 54F; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.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: 0001825034-2020-00366.

Event Description

It was reported that while implanting the liner into the acetabular shell, the surgeon noted it does not lock in place.He tried several times and finally decided to remove the shell.The surgery was completed with an alternate device.No adverse consequences were reported.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4, b5, d10.Corrected: d1, d2, d4, g5.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4: udi#: (b)(4).The following sections were updated/corrected updated: b4, b5, d4, g4, g7, h2, h3, h4, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4: udi#: (b)(4).The event was confirmed with product received.Visual inspection found the liner to be indecent overall condition.Scratches exist on the bottom of the inner radius near the apical hole plug.The 3 screw hole plugs remain intact.No damage was observed to the locking groove or scallop cutouts.A small amount of foreign material remains stuck to the porous coating.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.

• Brand Name: G7 PPS LTD ACET SHELL 54F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9617420
• MDR Text Key: 201771374
• Report Number: 0001825034-2020-00365
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000664
• Device Lot Number: 6587009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 01/22/2020
• Supplement Dates Manufacturer Received: 03/19/2020; 09/21/2020; 12/11/2020
• Supplement Dates FDA Received: 03/20/2020; 09/30/2020; 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CAT#: 010000897 G7 LINER LOT#: 6438627