MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 15MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 04/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 110010265 ¿ g7 cup - 6669380.010001032 ¿ cocr femoral head ¿ 6458261.30124006 ¿ g7 high wall liner ¿ 64561727.11-301341 ¿ arcos cone ¿ 215930.Unknown arcos stem ¿ unknown part and lot.010000996 ¿ g7 screw ¿ 6379063.010000996 ¿ g7 screw ¿ 6596562.010000996 ¿ g7 screw ¿ 6059231.010000996 ¿ g7 screw ¿ 6596562.010000996 ¿ g7 screw ¿ 6017218.010000996 ¿ g7 screw ¿ 6611150.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.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: 0001825034-2020-02256.0001825034 - 2020 - 02806.0001825034 - 2020 - 02807.0001825034 - 2020 - 02808.0001825034 - 2020 - 02810.0001825034 - 2020 - 02811.

Event Description

It was reported that patient underwent a left hip revision approximately 22 years post implantation, and a second revision approximately 2 months later.Subsequently, the patient experienced a fall and it was found that the cup component had dislodged and was replaced approximately 5 days later.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.The following sections were updated/corrected updated: d4; g4; h2; h3; h4; h6.Corrected: d11.D11: 010000998 ¿ g7 screw ¿ 6596562.010000996 ¿ g7 screw ¿ 6596562.010000997 ¿ g7 screw ¿ 6017218.010000999 ¿ g7 screw ¿ 6611150.010000996 ¿ g7 screw ¿ 6188923.Reported event was unable to be confirmed due to limited information provided by the customer.Dhr was reviewed and no discrepancies were found.It was reported that the patient had a fall which could have contributed to the reported event however a definitive root cause could not 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 additional event information to report at this time.

• Brand Name: G7 SCREW 6.5MM X 15MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10289138
• MDR Text Key: 199279385
• Report Number: 0001825034-2020-02809
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• 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: 010000996
• Device Lot Number: 6059231
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.; SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR