MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 DUAL MOBILITY ACETABULAR SYSTEM; PROSTHESIS, HIP

Catalog Number	110024464
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	01/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: (b)(6) item name bearing 28 mm i.D.44 mm o.D.Size f lot # 66882645; (b)(6) item name bioloxâ® delta, ceramic femoral head, l, 㸠28/+3.5, taper 12/14 lot # 3201313.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient underwent a revision procedure 26 days post implantation due to a twisting injury causing pain and dislocation.The stem was retained and all other implants were revised without complication.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; e1; h2.The following sections were corrected: a2; b7; d1; d5; g2.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h4; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records/radiographs were provided.Review of the available records identified the following: patient had an initial right tha and had a revision due to a twisting injury causing pain and superior dislocation.Stem was stable.The cup was a little anteverted but not bad, but it was decided to revise the cup.A post-revision x-ray reports good position and alignment with no evidence of failure or loosening.A definitive root cause cannot be determined.Based on the medical records, the complaint is 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.
Event or Problem Description
No further information is available at the time of this report.

• Brand Name: G7 DUAL MOBILITY ACETABULAR SYSTEM
• Common Device Name: PROSTHESIS, 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: 21515827
• Report Number: 0001825034-2025-00544
• Device Sequence Number: 20826656
• Product Code: LPH
• UDI-Device Identifier: 00880304703520
• UDI-Public: (01)00880304703520(17)340906(10)66624090
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K150522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2025

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 Catalogue Number: 110024464
• Device Lot Number: 66624090
• 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: 02/08/2025
• Supplement Date Received by Manufacturer: 05/15/2025; 07/03/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 06/11/2025; 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: White