MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 50MM D; HIP PROSTHESIS

Model Number	N/A
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed that no visible damage was noted on either the scallop or the locking features of the shell/cup.Scratches were identified on the rim and inside of the shell.Device history record was reviewed and no discrepancies were found.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
It was reported that the liner would not seat in cup.Due to malfunction, surgery was delayed for more than 2 hours.Patient's bone was noted to be fractured.Attempts have been made, and no further information has been provided.

• Brand Name: G7 OSSEOTI MULTIHOLE 50MM D
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8141451
• Report Number: 3002806535-2018-01216
• Device Sequence Number: 19304852
• Product Code: LPH
• UDI-Device Identifier: 00880304544383
• UDI-Public: (01)00880304544383
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140669
• 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
• Report Date (Section B): 12/07/2018

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: 110010263
• Device Lot Number: 6234910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention