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

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: G7 HI-WALL E1 LINER 36MM D
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10641333
• Report Number: 0001825034-2020-03651
• Device Sequence Number: 1178544
• Product Code: PBI
• UDI-Device Identifier: 00880304527096
• UDI-Public: (01)00880304527096
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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 Expiration Date: 03/02/2025
• 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
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 11/13/2020
• 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: NI
• Patient Sequence Number: 1
• Patient Age: 57 YR