MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 36MM D; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source (b)(6).Customer has indicated that the product will not be returned for evaluation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00194.Doi: does the use of the largest possible metal head increase the wear of vitamin e-doped cross-linked polyethylene? two-year results from a randomized controlled trial.10.1302/0301-620x.103b7.Bjj-2020-2064.R1.
Event or Problem Description
It was reported in a journal article that one patient experienced 2 postoperative dislocations treated with closed reduction.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
D10: 110010243 ¿ g7 shell ¿ 3426582.192012 ¿ echo stem ¿ 182890.Reported event was unable to be confirmed due to limited information provided by the customer.Dhr was reviewed and no discrepancies were found.The root cause is unable to 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
It was reported in a journal article that one patient reported testing hip mobility with friends when the hip dislocated after an unknown amount of time post total hip arthroplasty.Subsequently, the patient experienced a second dislocation after an unknown amount of time.Both dislocations were treated with closed reduction.No revision surgery has been reported to date.Attempts have been made and no additional event information is available at this time.

• Brand Name: G7 NEUTRAL E1 LINER 36MM D
• 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: 13359941
• Report Number: 0001825034-2022-00196
• Device Sequence Number: 11361590
• Product Code: PBI
• UDI-Device Identifier: 00880304526419
• UDI-Public: (01)00880304526419(10)3380952(17)190716
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000856
• Device Lot Number: 3380952
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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
• Usage of Device: Initial
• 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
• Patient Age: 55 YR
• Patient Sex: Female