MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM D; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 11 months post implantation of a right total hip arthroplasty, the patient was revised due to four dislocations which occurred on unspecified dates.The dislocations were not related to falls.It was reported that the patient arrived for the revision surgery walking.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat# 110010243 lot# g7 osseoti 3 hole shell 50mm d.Cat# 00-6250-065-30 lot# j7356061 trilogy bone scr 6.5x30.Cat# 01.06010.108 lot# 3151673 avenir muller stem 8 lateral.Cat# 802203602 lot# 2994091 zb 12/14 cocr hd 36mm x +0.G2: foreign: country: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;g3;h2;h3;h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.A definitive root cause cannot be determined.The complaint cannot be confirmed.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: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20567772
• Report Number: 0001825034-2024-02553
• Device Sequence Number: 20787541
• Product Code: PBI
• UDI-Device Identifier: 00880304527096
• UDI-Public: (01)00880304527096(17)270928(10)7339289
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

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: 010000934
• Device Lot Number: 7339289
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male