MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 LONGEVITY HIGH WALL 32MM E; PROSTHESIS, HIP

Catalog Number	20123205
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat #: 00877503202 / biolox⮠delta, ceramic femoral head, m, 㸠32/0, taper 12/14 / 3102189.The device will not be returned for analysis; 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 a patient was prescribed a hip abduction brace approximately two months¿ post implantation due to a dislocation, to be worn for six weeks.Subsequently, the patient underwent an internal reduction approximately eight months¿ post implantation due to a recurring dislocation.The patient was also prescribed an abduction brace after the procedure.To date, no revision has been scheduled and all implants remain in place.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed on (b)(6) 2022.3 weeks post op, the patient was prescribed otc topical medication for pain which is a normal finding.Subsequently on (b)(6) 2022, the hip dislocated while in the shower and an abduction brace was ordered for 6 weeks.The patient dislocated again on (b)(6) 2023 and another brace was ordered.No revision has occurred to date.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total hip arthroplasty with developing radiolucency along the acetabular cup which could indicate loosening.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot be determined.It was reported the patient dislocated due to bending, however that occurred more than 6 weeks post op.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 event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: g3, g6, h2, h3, h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Additional medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient experienced repeat dislocations, however lysis, loosening or wear was not noted.A revision has not been performed at this time.Root cause unchanged.This complaint was confirmed based on the provided medical records.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: G7 LONGEVITY HIGH WALL 32MM E
• 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: 17209217
• Report Number: 0001822565-2023-01702
• Device Sequence Number: 15119879
• Product Code: LPH
• UDI-Device Identifier: 00889024519275
• UDI-Public: (01)00889024519275(17)241231(10)64615803
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/21/2025

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 Expiration Date: 12/31/2024
• Device Catalogue Number: 20123205
• Device Lot Number: 64615803
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 08/07/2023; 05/19/2025
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 08/11/2023; 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2019
• 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: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White