MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM D; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Code Available (3191)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Concomitant medical products: 010000662-g7 pps ltd acet shell 50d-6405788, 010000934-g7 hi-wall e1 liner 36mm d-6122669.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03649, 0001825034-2020-03652.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a hip procedure the surgeon could not get the g7 liner to seat the g7 50 mm shell.After trying to seat another liner into the g7 50 mm shell with no success the surgeon changed to a 52 mm shell that didn¿t seat at the beginning.Subsequently the patient suffered a minor fracture after a heavy blow.The 52 mm shell finally seated the liner.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.A g7 hi-wall e1 liner 36mm d, part # 010000934 from lot 6760359, was returned and evaluated against the complaint.The liner is assembled with the shell upon receipt.The visible portions of the liner are mostly free of damage.The outside of the elevated portion of the liner has been gouge/indented.The mating surface between the liner and shell is visually smooth and flush to the touch.A review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.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

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

• Brand Name: G7 HI-WALL E1 LINER 36MM D
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10641333
• MDR Text Key: 211101784
• Report Number: 0001825034-2020-03651
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527096
• UDI-Public: (01)00880304527096
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• 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: 010000934
• Device Lot Number: 6760359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Age: 57 YR