MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 10 DEG ARCOMXL LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 07/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).G7 10 deg arcomxl liner 36mm f, pn 010000780, ln 6329035, g7 pps ltd acet shell 56f, pn 010000665, ln 6335983, cer bioloxd option hd 36mm, pn 650-1057, ln 2982638, cer opt type 1 tpr sleve 0mm, pn 650-1066, ln 2955122, unknown stem, pn unknown, ln unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03929.Customer has indicated that the product has been returned to zimmer biomet for investigation.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 underwent a total hip arthroplasty.Subsequently, the patient suffered a minor fall.The patient was then revised approximately one month after the initial surgery, due to the liner disassociating from the cup.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.

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.Udi: (b)(4).Complaint sample was evaluated and the reported event was confirmed.Reported event was confirmed by review of one g7 10 deg arcomxl liner 36mm f which was returned and evaluated.Upon visual inspection the liner has been damaged.The locking feature is missing in two locations around the liner and the scallops show damage completely around the liner.Device history record (dhr) was reviewed and no discrepancies 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 10 DEG ARCOMXL LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9007165
• MDR Text Key: 157799384
• Report Number: 0001825034-2019-03928
• 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: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000780
• Device Lot Number: 6329035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 07/14/2018
• Supplement Dates FDA Received: 12/27/2019
• 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
• Patient Age: 51 YR