MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 62MM H; PROSTHESIS HIP

Catalog Number	110010269
Medical Device Problem Codes	Material Erosion (1214); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Metal Related Pathology (4530)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product was requested but not returned by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part 163662/ mod hd std neck tp1 taper/ lot # 752810, part # unknown/ unknown stem / lot # unknown , part #ep-200156/ act artic e1 hip brg/ lot # 376350, part# 110024466/ g7 dual mobility liner 50mm h/ lot# 392790, part# 00625006550/ bone scr 6.5x50 self-tap/ lot# j6801146.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -03098, 0001825034 -2021 -03099.
Event or Problem Description
It was reported that patient underwent a hip revision 6 months post implantation due to cup not obtaining biological fixation.Metallosis was noted.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 confirmed via radiographs reviewed by a health care professional.No product was returned; visual and dimensional evaluations could not be performed.Visual inspection of the explanted product identified bio debris on the shell porous surface.The head assembled with bearing and dual mobility liner identified blood on the devices from removal.Review of the device history records identified no (related) deviations or anomalies during manufacturing.A definitive root cause could not 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 additional information on the reported event.

• Brand Name: G7 OSSEOTI MULTIHOLE 62MM H
• Common Device Name: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12817210
• Report Number: 0001825034-2021-03097
• Device Sequence Number: 14877119
• Product Code: JDI
• UDI-Device Identifier: 00887868356070
• UDI-Public: (01)00887868356070(17)310202(10)6952469
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

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 Catalogue Number: 110010269
• Device Lot Number: 6952469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 70 KG