MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 32MM C; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).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 an initial operation, the implantation of the g7 high wall e1 liner 32mm c was obstructed when the external acetabular cup was implanted into the patient.It was found that the liner could not be completely implanted into the external acetabular cup (it could not reach the bottom and could not be implanted in the proper place).After many tries, still fails.Eventually the doctor replaced it with a ceramic lining and completed the operation.Due to repeated operation, the operation was delayed for 15 minutes.The surgeon strictly followed the surgical technique and did not perform any improper operation.No adverse events have been reported as a result of the malfunction.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.Device was returned and evaluated.Upon visual inspection the device locking feature has shavings of material on it.The outside diameter and scallops do not show any visible damage.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: G7 HI-WALL E1 LINER 32MM C
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11011212
• Report Number: 0001825034-2020-04360
• Device Sequence Number: 869881
• Product Code: JDI
• UDI-Device Identifier: 00880304527010
• UDI-Public: (01)00880304527010
• 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): 01/20/2021

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 Expiration Date: 01/16/2025
• Device Model Number: N/A
• Device Catalogue Number: 010000925
• Device Lot Number: 6728486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/22/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/20/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BIOMET G7 SHELL CAT#010000661 LOT#6527555; UNKNOWN CUP; UNKNOWN CUP
• Patient Age: 72 YR
• Patient Weight: 70