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 Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Dob: unknown date in 1956.Foreign country: (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 the surgeon was unable to break into stability when he cracked down on the lining.It was not possible to step down at the time, and was only able to implant ceramic linings later.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device was returned and evaluated.Upon visual inspection the device has multiple circular indentations on the outer radius.The locking feature and the scallops show no damage.No further measurements were taken due to impaction.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• 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: 10200973
• Report Number: 0001825034-2020-02487
• Device Sequence Number: 14106756
• Product Code: PBI
• UDI-Device Identifier: 00880304527096
• UDI-Public: (01)00880304527096(17)240529(10)6553696
• 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): 09/03/2020

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: 05/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 010000934
• Device Lot Number: 6553696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 09/03/2020
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CUP
• Patient Age: 71 YR
• Patient Weight: 49