MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 48MM C; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign country: (b)(6).Concomitant medical devices: zimmer bone scr 6.5x20 self-tap cat#00625006520 lot#64536479; zimmer bone scr 6.5x20 self-tap cat#00625006520 lot#64580133; zimmer bone scr 6.5x20 self-tap cat#00625006520 lot#64540462; unknown liner; unknown stem; unknown head.The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported a patient underwent revision surgery due to frequent dislocations.After the surgery, the radiograph showed one of the screws had penetrated the shell.No revision has been reported to due this event.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.Reported event was unable to be confirmed due to limited information received from the customer.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: G7 OSSEOTI MULTIHOLE 48MM C
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10441961
• Report Number: 0001825034-2020-03313
• Device Sequence Number: 19837692
• Product Code: LPH
• UDI-Device Identifier: 00887868356001
• UDI-Public: (01)00887868356001(17)300321(10)6742931
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110010262
• Device Lot Number: 6742931
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 08/28/2020
• 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
• Outcome Attributed to Adverse Event: Other