MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 STR MONOBLOCK SHELL INSRTR; INSTRUMENT, HIP

Model Number	N/A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Product has been returned to zimmer biomet for investigation.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 - 04412.
Event or Problem Description
It was reported while impacting the shell after determining it¿s appropriate connection to the handle, there was a locking effect which meant the handle could not be unscrewed and needed to be removed and another implanted from a different system.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6 the inserter was returned.The shell was assembled and disassemble with the inserter 3 times.No seizing or locking was experienced.The shell was able to be fully seated during each attempt.The face of the inserter is sits flush with the surface of the shell when fully seated.A review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event for the inserter.Medical records were not provided.After review of the product, no problem was found as they functioned as intended and assembled and disassembled multiple times.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: G7 STR MONOBLOCK SHELL INSRTR
• Common Device Name: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11614479
• Report Number: 0001825034-2021-00978
• Device Sequence Number: 14339335
• Product Code: PBI
• UDI-Device Identifier: 00880304532694
• UDI-Public: (01)00880304532694(11)180209(10)992170
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110003450
• Device Lot Number: 992170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1