MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BEARING 28 MM I.D. 44 MM O.D. SIZE F; PROSTHESIS, HIP

Catalog Number	110031000
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
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).D10: 110024464 item name: g7 dual mobility liner 44mm f, lot # 66624090; 00877502803 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10 - associated products: part #: 110024464 item name: g7 dual mobility liner 44mm f lot #: 66624090.Part #: 00877502803 item name: bioloxâ® delta, ceramic femoral head lot #: 3201313.Part #: 110010246 item name: g7 osseoti 4 hole shell lot #: 65273587.Part #: 574202050 item name: femoral stem cementless lot #: 3205956.Part #: 110034355 item name: refobacin bc r 1x40 us lot #: w50eal1501.
Event or Problem Description
It was reported that a patient had an initial right total hip arthroplasty followed by a revision 1 month later due to unresolved pain and weakness.During this procedure the cup was retained but was noted as ¿a little under anteverted.¿ subsequently, the patient was revised a second time approximately 1 month later following a twisting injury causing pain and dislocation.The stem was retained, and all other implants were revised without complication.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: g3; h2; h3; 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.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patient had a initial right tha.Patient had a revision due to a twisting injury causing pain and superior dislocation.Contributing factor was the cup was a little anteverted but not bad, but it was decided to revise the cup.An 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 at the time of this report.

• Brand Name: BEARING 28 MM I.D. 44 MM O.D. SIZE F
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21515832
• Report Number: 0001822565-2025-00522
• Device Sequence Number: 20826757
• Product Code: LPH
• UDI-Device Identifier: 00889024572584
• UDI-Public: (01)00889024572584(17)290825(10)66882645
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K190656
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2025

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: Lay User/Patient
• Device Catalogue Number: 110031000
• Device Lot Number: 66882645
• 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; 07/01/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 06/10/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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