MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 STR INSRTR THREADED SHAFT; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item number: unknown, item name: unknown g7 cup, lot number: unknown.Foreign report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during an initial hip arthroplasty the shell inserter fractured.No consequences or impact to patient were reported.Attempts have been made and no additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H4: the manufacturing date is either sep 26, 2013 or apr 4, 2014.Reported event was confirmed with product return.Visual inspection confirms that the threaded tip of the inserter has fractured.Approximately one thread has fractured off.Nicks and dings were observed to the chuck.Wear rings were found on the proximal end.The etch has faded and small surface scratches were found sporadically over the inserter.Fracture analysis demonstrated that the fracture surface features of the straight inserter align with bending overload of the threaded tip.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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

It was reported during an initial hip arthroplasty the shell inserter fractured and the fractured piece was left inside shell implant, in the patient body.No consequences or impact to patient were reported.No additional information is available.

• Brand Name: G7 STR INSRTR THREADED SHAFT
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9097408
• MDR Text Key: 195176830
• Report Number: 0001825034-2019-04205
• Device Sequence Number: 1
• Product Code: OQG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• 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: 110003452
• Device Lot Number: 355235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other